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CompletedNCT01183013Updated Oct 20, 2014Results posted

30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

A Phase 3 interventional study of Pioglitazone 15 mg and Pioglitazone 45 mg in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 132 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
936
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 936 is above the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to \<= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
  3. Age >= 18 and \<= 80 years at start date of Visit 1 (Screening)
  4. BMI \<= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
  5. Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Exclusion criteria

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
  2. Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
  3. Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
  4. Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
  5. Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
  6. Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)

  7. Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :

    • Diagnose of heart failure or history of heart failure
    • Haemodialysis patients, due to limited experience with pioglitazone
  8. Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
  9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
  11. Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
  12. Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures

  15. Pre-menopausal women (last menstruation \<= 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.

    A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner

  16. Symptomatic gallbladder disease in the last six months
  17. Medical history of pancreatitis.
  18. Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
  19. Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
936 participants (actual)

Study arms

  • Active comparator
    Pioglitazone 15 mg

    Pioglitazone Capsules 15 mg once daily

    Drug: Pioglitazone 15 mg

  • Active comparator
    Pioglitazone 30 mg

    Pioglitazone Capsules 30 mg once daily

    Drug: Pioglitazone 30 mg

  • Active comparator
    Pioglitazone 45 mg

    Pioglitazone Capsules 45 mg once daily

    Drug: Pioglitazone 45 mg

  • Active comparator
    Linagliptin 5mg

    Linagliptin 5mg Tablets once daily

    Drug: Linagliptin 5mg

  • Experimental
    Linagliptin 5mg / Pioglitazone 15 mg

    Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily

    Drug: Linagliptin 5mg / Pioglitazone 15 mg FDC

  • Experimental
    Linagliptin 5mg / Pioglitazone 30 mg

    Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily

    Drug: Linagliptin 5mg / Pioglitazone 30 mg FDC

  • Experimental
    Linagliptin 5mg / Pioglitazone 45 mg

    Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily

    Drug: Linagliptin 5mg / Pioglitazone 45 mg FDC

Interventions

  • DrugPioglitazone 15 mg

    Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks

  • DrugPioglitazone 45 mg

    Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks

  • DrugPioglitazone 30 mg

    Pioglitazone Capsules 30 mg once daily for up to 84 weeks

  • DrugLinagliptin 5mg / Pioglitazone 45 mg FDC

    Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks

  • DrugLinagliptin 5mg / Pioglitazone 30 mg FDC

    Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks

  • DrugLinagliptin 5mg

    Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

  • DrugLinagliptin 5mg / Pioglitazone 15 mg FDC

    Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks

06

What researchers measure

Primary outcomes

  1. Change From Baseline in HbA1c After 30 Weeks of Treatment.

    HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.

    Time frame: Baseline and 30 weeks

Secondary outcomes

  1. Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

    Time frame: Baseline and 30 weeks

  2. Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

    Time frame: Baseline and 30 weeks

  3. Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)

    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

    Time frame: Baseline and 30 weeks

  4. HbA1c Change From Baseline by Visit Over Time

    HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction.

    Time frame: Baseline, week 6, week 12, week 18, week 24, week 30

  5. Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment

    The change from baseline is the FPG after 30 weeks minus the baseline FPG.

    Time frame: Baseline and 30 weeks

  6. Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time

    The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction

    Time frame: Baseline, week 6, week 12, week 18, week 24, week 30

  7. Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)

    The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.

    Time frame: Baseline and 30 weeks

  8. Time to First Use of Rescue Therapy

    Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.

    Time frame: 30 weeks

  9. Incidence of Rescue Therapy During the First 30 Weeks of Treatment

    Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.

    Time frame: 30 weeks

07

Results

Posted Apr 21, 2014
Limitations and caveats
The study (Part B treatment only) was stopped early by protocol amendment #5, although Part A (time frame for all efficacy outcomes) proceeded to completion

Participant flow

After Amendment #5, patients were considered COMPLETED at the end of Part A (30 weeks) or after their next Part B visit (up to 54 weeks) if already in Part B. Before Amendment #5, all patients were considered COMPLETED at the end of Part A + Part B (84 weeks).

Participant flow — Overall Study
MilestonePio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45
Started131140138135126133133
Completed8610197105908896
Not completed45394130364537
Withdrew: Adverse event685510106
Withdrew: Lack of efficacy3212120
Withdrew: Protocol violation5240433
Withdrew: Lost to follow-up7343265
Withdrew: Withdrawal by subject9131087910
Withdrew: Reasons other than stated above15111712121513

Outcome measures

PrimaryChange From Baseline in HbA1c After 30 Weeks of Treatment.

HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.

Time frame:
Baseline and 30 weeks
Reported as:
Mean · percent
Change From Baseline in HbA1c After 30 Weeks of Treatment.
percentPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Change From Baseline in HbA1c After 30 Weeks of Treatment.-0.66 ± 0.09-0.69 ± 0.09-0.87 ± 0.09-0.39 ± 0.09-0.83 ± 0.09-1.06 ± 0.09-1.28 ± 0.09
Statistical analysis
  • Pio15 vs Lina5Pio15 · ANCOVA · p = 0.1571 (The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.) · Mean difference (final values): -0.17 · 95% CI -0.41 to 0.07
  • Pio30 vs Lina5Pio30 · ANCOVA · p = 0.0016 · Mean difference (final values): -0.37 · 95% CI -0.60 to -0.14The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
  • Pio45 vs Lina5Pio45 · ANCOVA · p = 0.0006 · Mean difference (final values): -0.41 · 95% CI -0.64 to -0.18The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio15 · ANCOVA · p = 0.0003 · Mean difference (final values): -0.44 · 95% CI -0.67 to -0.20The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio30 · ANCOVA · p = <0.0001 · Mean difference (final values): -0.68 · 95% CI -0.91 to -0.44The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio45 · ANCOVA · p = <0.0001 · Mean difference (final values): -0.89 · 95% CI -1.12 to -0.66The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
SecondaryOccurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

Time frame:
Baseline and 30 weeks
Reported as:
Number · participants
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
participantsPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment39556829456181
Statistical analysis
  • Pio15 vs Lina5Pio15 · Regression, Logistic · p = 0.4639 · Odds ratio (or): 1.246 · 95% CI 0.692 to 2.242A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio30 vs Lina5Pio30 · Regression, Logistic · p = 0.0546 · Odds ratio (or): 1.746 · 95% CI 0.989 to 3.083A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio45 vs Lina5Pio45 · Regression, Logistic · p = 0.0254 · Odds ratio (or): 1.903 · 95% CI 1.083 to 3.345A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio15 · Regression, Logistic · p = 0.0009 · Odds ratio (or): 2.804 · 95% CI 1.524 to 5.159A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio30 · Regression, Logistic · p = <0.0001 · Odds ratio (or): 5.429 · 95% CI 2.947 to 10.001A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio45 · Regression, Logistic · p = <0.0001 · Odds ratio (or): 9.614 · 95% CI 5.187 to 17.821A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
SecondaryOccurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

Time frame:
Baseline and 30 weeks
Reported as:
Number · participants
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
participantsPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment20283914243843
Statistical analysis
  • Pio15 vs Lina5Pio15 · Regression, Logistic · p = 0.7359 · Odds ratio (or): 1.126 · 95% CI 0.565 to 2.243A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio30 vs Lina5Pio30 · Regression, Logistic · p = 0.0363 · Odds ratio (or): 1.905 · 95% CI 1.042 to 3.484A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio45 vs Lina5Pio45 · Regression, Logistic · p = 0.4039 · Odds ratio (or): 1.269 · 95% CI 0.726 to 2.217A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio15 · Regression, Logistic · p = 0.0345 · Odds ratio (or): 2.220 · 95% CI 1.060 to 4.649A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio30 · Regression, Logistic · p = <0.0001 · Odds ratio (or): 4.580 · 95% CI 2.263 to 9.266A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio45 · Regression, Logistic · p = <0.0001 · Odds ratio (or): 5.066 · 95% CI 2.530 to 10.145A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
SecondaryOccurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

Time frame:
Baseline and 30 weeks
Reported as:
Number · participants
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
participantsPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)798390547991107
Statistical analysis
  • Pio15 vs Lina5Pio15 · Regression, Logistic · p = 0.7540 · Odds ratio (or): 1.090 · 95% CI 0.637 to 1.863A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio30 vs Lina5Pio30 · Regression, Logistic · p = 0.0506 · Odds ratio (or): 1.707 · 95% CI 0.999 to 2.918A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio45 vs Lina5Pio45 · Regression, Logistic · p = 0.0005 · Odds ratio (or): 2.966 · 95% CI 1.604 to 5.485A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio15 · Regression, Logistic · p = 0.0002 · Odds ratio (or): 2.696 · 95% CI 1.594 to 4.559A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio30 · Regression, Logistic · p = <0.0001 · Odds ratio (or): 4.017 · 95% CI 2.348 to 6.873A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio45 · Regression, Logistic · p = <0.0001 · Odds ratio (or): 8.521 · 95% CI 4.630 to 15.681A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
SecondaryHbA1c Change From Baseline by Visit Over Time

HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction.

Time frame:
Baseline, week 6, week 12, week 18, week 24, week 30
Reported as:
Mean · percent
HbA1c Change From Baseline by Visit Over Time
percentPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Change to week 6 (N=121,133,133,130,119,124,125)-0.22 ± 0.06-0.16 ± 0.06-0.20 ± 0.06-0.23 ± 0.06-0.43 ± 0.06-0.47 ± 0.06-0.62 ± 0.06
Change to week 12 (N=112,124,127,122,111,117,120)-0.47 ± 0.08-0.43 ± 0.07-0.59 ± 0.07-0.36 ± 0.08-0.71 ± 0.08-0.92 ± 0.08-1.01 ± 0.08
Change to week 18 (N=101,121,122,112,104,104,115)-0.63 ± 0.09-0.58 ± 0.08-0.82 ± 0.08-0.39 ± 0.08-0.81 ± 0.09-1.07 ± 0.09-1.22 ± 0.09
Change to week 24 (N=91,108,110,95,92,96,109)-0.75 ± 0.09-0.67 ± 0.09-0.87 ± 0.09-0.39 ± 0.09-0.84 ± 0.09-1.10 ± 0.09-1.23 ± 0.09
Change to week 30 (N=78,93,91,79,86,87,97)-0.77 ± 0.09-0.73 ± 0.08-0.94 ± 0.09-0.37 ± 0.09-0.87 ± 0.09-1.09 ± 0.09-1.27 ± 0.09
SecondaryFasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment

The change from baseline is the FPG after 30 weeks minus the baseline FPG.

Time frame:
Baseline and 30 weeks
Reported as:
Mean · mg/dL
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
mg/dLPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment-15.16 ± 3.49-25.49 ± 3.28-28.69 ± 3.29-1.46 ± 3.35-18.84 ± 3.47-27.33 ± 3.46-35.19 ± 3.40
Statistical analysis
  • Pio15 vs Lina5Pio15 · ANCOVA · p = 0.4275 · Mean difference (final values): -3.68 · 95% CI -12.77 to 5.42The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
  • Pio30 vs Lina5Pio30 · ANCOVA · p = 0.6839 · Mean difference (final values): -1.84 · 95% CI -10.69 to 7.02The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
  • Pio45 vs Lina5Pio45 · ANCOVA · p = 0.1466 · Mean difference (final values): -6.50 · 95% CI -15.29 to 2.28The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio15 · ANCOVA · p = 0.0002 · Mean difference (final values): -17.38 · 95% CI -26.35 to -8.41The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio30 · ANCOVA · p = <0.0001 · Mean difference (final values): -25.87 · 95% CI -34.77 to -16.98The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio45 · ANCOVA · p = <0.0001 · Mean difference (final values): -33.73 · 95% CI -42.57 to -24.89The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
SecondaryFasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time

The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction

Time frame:
Baseline, week 6, week 12, week 18, week 24, week 30
Reported as:
Mean · mg/dL
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
mg/dLPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Change at week 6 (N=118,132,133,130,119,122,124)-14.43 ± 2.99-16.38 ± 2.80-15.72 ± 2.81-4.25 ± 2.84-19.25 ± 2.96-26.89 ± 2.94-28.36 ± 2.89
Change at week 12 (N=111,124,126,122,108,114,118)-10.63 ± 3.24-21.36 ± 3.04-25.30 ± 3.03-7.43 ± 3.08-17.99 ± 3.24-31.25 ± 3.19-28.53 ± 3.13
Change at week 18 (N=100,122,121,111,104,103,114)-16.68 ± 3.29-20.69 ± 3.02-28.68 ± 3.03-7.06 ± 3.13-19.01 ± 3.24-31.22 ± 3.25-30.66 ± 3.12
Change at week 24 (N=90,108,108,96,93,93,108)-16.25 ± 3.25-21.57 ± 2.99-27.67 ± 3.00-4.60 ± 3.13-16.68 ± 3.20-31.48 ± 3.20-31.49 ± 3.03
Change at week 30 (N=76,91,89,79,82,87,98)-17.66 ± 3.35-26.09 ± 3.08-31.76 ± 3.11-0.09 ± 3.24-17.93 ± 3.27-27.11 ± 3.22-34.04 ± 3.07
SecondaryTwo-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)

The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.

Time frame:
Baseline and 30 weeks
Reported as:
Least squares mean · mg/dL
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
mg/dLPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)-30.65 ± 10.93-83.00 ± 9.85-82.98 ± 10.92-51.61 ± 11.67-67.26 ± 11.15-87.94 ± 11.14-84.77 ± 10.28
Statistical analysis
  • Pio15 vs Lina5Pio15 · ANCOVA · p = 0.0057 · Mean difference (final values): -36.61 · 95% CI -62.42 to -10.80The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
  • Pio30 vs Lina5Pio30 · ANCOVA · p = 0.7021 · Mean difference (final values): -4.94 · 95% CI -30.39 to 20.51The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
  • Pio45 vs Lina5Pio45 · ANCOVA · p = 0.8932 · Mean difference (final values): -1.78 · 95% CI -27.95 to 24.38The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio15 · ANCOVA · p = 0.2706 · Mean difference (final values): -15.65 · 95% CI -43.60 to 12.30The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio30 · ANCOVA · p = 0.0126 · Mean difference (final values): -36.33 · 95% CI -64.78 to -7.89The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
  • Lina5 vs Lina5Pio45 · ANCOVA · p = 0.0167 · Mean difference (final values): -33.16 · 95% CI -60.23 to -6.08The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
SecondaryTime to First Use of Rescue Therapy

Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.

Time frame:
30 weeks
Reported as:
Number · Proportion of participants
Time to First Use of Rescue Therapy
Proportion of participantsPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Proportion event-free0.8117 ± 50.50.8533 ± 47.80.9051 ± 55.30.7756 ± 47.70.8854 ± 61.50.9078 ± 54.70.9548 ± 65.7
Standard Error0.03820.03300.02730.03900.03130.02790.0198
SecondaryIncidence of Rescue Therapy During the First 30 Weeks of Treatment

Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.

Time frame:
30 weeks
Reported as:
Number · participants
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
participantsPio15Pio30Pio45Lina5Lina5Pio15Lina5Pio30Lina5Pio45
Incidence of Rescue Therapy During the First 30 Weeks of Treatment2017112612105
Statistical analysis
  • Pio15 vs Lina5Pio15 · Regression, Logistic · p = 0.3052 · Odds ratio (or): 0.649 · 95% CI 0.284 to 1.482A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio30 vs Lina5Pio30 · Regression, Logistic · p = 0.0844 · Odds ratio (or): 0.456 · 95% CI 0.187 to 1.112A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Pio45 vs Lina5Pio45 · Regression, Logistic · p = 0.1561 · Odds ratio (or): 0.443 · 95% CI 0.143 to 1.365A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio15 · Regression, Logistic · p = 0.0146 · Odds ratio (or): 0.368 · 95% CI 0.165 to 0.821A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio30 · Regression, Logistic · p = 0.0009 · Odds ratio (or): 0.238 · 95% CI 0.102 to 0.557A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
  • Lina5 vs Lina5Pio45 · Regression, Logistic · p = 0.0002 · Odds ratio (or): 0.141 · 95% CI 0.050 to 0.397A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.

Adverse events

Collected over Up to 85 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pio15/Pio30—9/131 (6.9%)57/131 (43.5%)
Pio30/Pio30—9/140 (6.4%)55/140 (39.3%)
Pio45/Pio45—5/138 (3.6%)66/138 (47.8%)
Lina5/Lina5—9/135 (6.7%)57/135 (42.2%)
Lina5Pio15/Lina5Pio30—9/126 (7.1%)52/126 (41.3%)
Lina5Pio30/Lina5Pio30—15/133 (11.3%)58/133 (43.6%)
Lina5Pio45/Lina5Pio45—10/133 (7.5%)56/133 (42.1%)
Most frequent serious events
Showing 10 of 84
Most frequent serious events
EventPio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45
Acute myocardial infarctionCardiac disorders0/1311/1400/1380/1350/1262/1330/133
Chest painGeneral disorders0/1310/1400/1382/1350/1260/1330/133
Atrial fibrillationCardiac disorders0/1310/1401/1380/1351/1260/1331/133
Supraventricular tachycardiaCardiac disorders0/1310/1400/1380/1351/1261/1330/133
Basedow's diseaseEndocrine disorders0/1310/1400/1380/1351/1260/1330/133
Abdominal pain upperGastrointestinal disorders0/1310/1400/1380/1351/1260/1330/133
CholestasisHepatobiliary disorders0/1310/1400/1380/1351/1260/1330/133
PyelonephritisInfections and infestations0/1310/1400/1380/1351/1260/1330/133
HypoglycaemiaMetabolism and nutrition disorders0/1310/1400/1380/1351/1260/1330/133
ArthralgiaMusculoskeletal and connective tissue disorders0/1310/1400/1380/1351/1260/1330/133
Most frequent other events
Showing 10 of 14
Most frequent other events
EventPio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45
Oedema peripheralGeneral disorders13/13111/14011/1386/1358/1269/13315/133
HyperglycaemiaMetabolism and nutrition disorders9/13110/1405/13814/1358/1268/1335/133
Back painMusculoskeletal and connective tissue disorders12/1315/14010/1386/1358/1267/13312/133
HypertensionVascular disorders12/1314/1407/1389/1356/1265/1331/133
OedemaGeneral disorders4/1311/1407/1380/1350/12612/1334/133
DiarrhoeaGastrointestinal disorders2/1310/1405/1387/13510/1262/1333/133
NasopharyngitisInfections and infestations9/13110/1404/13810/1359/1268/1333/133
DizzinessNervous system disorders0/1317/1403/1384/1354/1269/1334/133
Upper respiratory tract infectionInfections and infestations2/1316/1409/1385/1354/1266/1336/133
ArthralgiaMusculoskeletal and connective tissue disorders3/1315/1409/1387/1351/1264/1334/133

Baseline characteristics

All patients from the Full Analysis Set (FAS) which includes those patients in the treated set who had a baseline HbA1c value and at least one on-treatment HbA1c value.

Age, Continuous
Age, Continuous(years)Pio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45Total
Mean56.4 ± 10.457.2 ± 11.156.5 ± 11.156.3 ± 10.157.1 ± 10.256.4 ± 10.060.1 ± 10.257.1 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Pio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45Total
Female57646651546157410
Male67706879666469483
Baseline HbA1c
Baseline HbA1c(percent)Pio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45Total
Mean8.33 ± 0.937.99 ± 0.858.12 ± 0.878.01 ± 0.888.13 ± 0.948.17 ± 1.078.01 ± 0.818.11 ± 0.91
Baseline fasting plasma glucose (FPG)
Baseline fasting plasma glucose (FPG)(mg/dL)Pio15/Pio30Pio30/Pio30Pio45/Pio45Lina5/Lina5Lina5Pio15/Lina5Pio30Lina5Pio30/Lina5Pio30Lina5Pio45/Lina5Pio45Total
Mean171.3 ± 39.3165.8 ± 40.0167.5 ± 37.9161.4 ± 38.1167.3 ± 39.5168.8 ± 46.8162.3 ± 36.8166.3 ± 39.9
08

Study locations

132 sites
  • 1264.3.01026 Boehringer Ingelheim Investigational Site
    Birmingham, Alabama, United States
  • 1264.3.01021 Boehringer Ingelheim Investigational Site
    Montgomery, Alabama, United States
  • 1264.3.01020 Boehringer Ingelheim Investigational Site
    Muscle Shoals, Alabama, United States
  • 1264.3.01062 Boehringer Ingelheim Investigational Site
    Chandler, Arizona, United States
  • 1264.3.01064 Boehringer Ingelheim Investigational Site
    Mesa, Arizona, United States
  • 1264.3.01049 Boehringer Ingelheim Investigational Site
    Carmichael, California, United States
  • 1264.3.01078 Boehringer Ingelheim Investigational Site
    Chino, California, United States
  • 1264.3.01031 Boehringer Ingelheim Investigational Site
    Concord, California, United States
  • 1264.3.01037 Boehringer Ingelheim Investigational Site
    Lakewood, California, United States
  • 1264.3.01065 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
  • 1264.3.01006 Boehringer Ingelheim Investigational Site
    Norwalk, California, United States
  • 1264.3.01001 Boehringer Ingelheim Investigational Site
    Rancho Cucamonga, California, United States
  • 1264.3.01059 Boehringer Ingelheim Investigational Site
    San Diego, California, United States
  • 1264.3.01023 Boehringer Ingelheim Investigational Site
    Tarzana, California, United States
  • 1264.3.01016 Boehringer Ingelheim Investigational Site
    Tustin, California, United States
  • 1264.3.01058 Boehringer Ingelheim Investigational Site
    Valencia, California, United States
  • 1264.3.01083 Boehringer Ingelheim Investigational Site
    Westlake Village, California, United States
  • 1264.3.01027 Boehringer Ingelheim Investigational Site
    Denver, Colorado, United States
  • 1264.3.01033 Boehringer Ingelheim Investigational Site
    Norwalk, Connecticut, United States
  • 1264.3.01035 Boehringer Ingelheim Investigational Site
    Boca Raton, Florida, United States
  • 1264.3.01015 Boehringer Ingelheim Investigational Site
    Clearwater, Florida, United States
  • 1264.3.01082 Boehringer Ingelheim Investigational Site
    Hialeah, Florida, United States
  • 1264.3.01036 Boehringer Ingelheim Investigational Site
    Jacksonville, Florida, United States
  • 1264.3.01013 Boehringer Ingelheim Investigational Site
    Longwood, Florida, United States
  • 1264.3.01038 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
  • 1264.3.01042 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
  • 1264.3.01079 Boehringer Ingelheim Investigational Site
    Miami, Florida, United States
  • 1264.3.01019 Boehringer Ingelheim Investigational Site
    Port Orange, Florida, United States
  • 1264.3.01018 Boehringer Ingelheim Investigational Site
    St. Cloud, Florida, United States
  • 1264.3.01009 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
  • 1264.3.01012 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
  • 1264.3.01008 Boehringer Ingelheim Investigational Site
    Atlanta, Georgia, United States
  • 1264.3.01055 Boehringer Ingelheim Investigational Site
    Atlanta, Georgia, United States
  • 1264.3.01061 Boehringer Ingelheim Investigational Site
    Atlanta, Georgia, United States
  • 1264.3.01074 Boehringer Ingelheim Investigational Site
    Blue Ridge, Georgia, United States
  • 1264.3.01084 Boehringer Ingelheim Investigational Site
    Cartersville, Georgia, United States
  • 1264.3.01060 Boehringer Ingelheim Investigational Site
    Perry, Georgia, United States
  • 1264.3.01050 Boehringer Ingelheim Investigational Site
    Savannah, Georgia, United States
  • 1264.3.01077 Boehringer Ingelheim Investigational Site
    Chicago, Illinois, United States
  • 1264.3.01052 Boehringer Ingelheim Investigational Site
    Brownsburg, Indiana, United States
  • 1264.3.01075 Boehringer Ingelheim Investigational Site
    Evansville, Indiana, United States
  • 1264.3.01076 Boehringer Ingelheim Investigational Site
    Evansville, Indiana, United States
  • 1264.3.01073 Boehringer Ingelheim Investigational Site
    Franklin, Indiana, United States
  • 1264.3.01002 Boehringer Ingelheim Investigational Site
    Wichita, Kansas, United States
  • 1264.3.01007 Boehringer Ingelheim Investigational Site
    Wichita, Kansas, United States
  • 1264.3.01010 Boehringer Ingelheim Investigational Site
    Lexington, Kentucky, United States
  • 1264.3.01028 Boehringer Ingelheim Investigational Site
    New Orleans, Louisiana, United States
  • 1264.3.01029 Boehringer Ingelheim Investigational Site
    Sunset, Louisiana, United States
  • 1264.3.01069 Boehringer Ingelheim Investigational Site
    Hyattsville, Maryland, United States
  • 1264.3.01066 Boehringer Ingelheim Investigational Site
    Southfield, Michigan, United States
  • 1264.3.01057 Boehringer Ingelheim Investigational Site
    Great Falls, Montana, United States
  • 1264.3.01045 Boehringer Ingelheim Investigational Site
    Burlington, North Carolina, United States
  • 1264.3.01044 Boehringer Ingelheim Investigational Site
    Charlotte, North Carolina, United States
  • 1264.3.01022 Boehringer Ingelheim Investigational Site
    Zanesville, Ohio, United States
  • 1264.3.01032 Boehringer Ingelheim Investigational Site
    Oklahoma City, Oklahoma, United States
  • 1264.3.01051 Boehringer Ingelheim Investigational Site
    Fleetwood, Pennsylvania, United States
  • 1264.3.01025 Boehringer Ingelheim Investigational Site
    Pittsburgh, Pennsylvania, United States
  • 1264.3.01081 Boehringer Ingelheim Investigational Site
    Columbia, South Carolina, United States
  • 1264.3.01003 Boehringer Ingelheim Investigational Site
    Greer, South Carolina, United States
  • 1264.3.01011 Boehringer Ingelheim Investigational Site
    Kingsport, Tennessee, United States
  • 1264.3.01017 Boehringer Ingelheim Investigational Site
    Corpus Christi, Texas, United States
  • 1264.3.01067 Boehringer Ingelheim Investigational Site
    Dallas, Texas, United States
  • 1264.3.01004 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • 1264.3.01039 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • 1264.3.01041 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • 1264.3.01047 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • 1264.3.01070 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • 1264.3.01040 Boehringer Ingelheim Investigational Site
    Killeen, Texas, United States
  • 1264.3.01048 Boehringer Ingelheim Investigational Site
    Midland, Texas, United States
  • 1264.3.01030 Boehringer Ingelheim Investigational Site
    New Braunfels, Texas, United States
  • 1264.3.01071 Boehringer Ingelheim Investigational Site
    North Richland Hills, Texas, United States
  • 1264.3.01085 Boehringer Ingelheim Investigational Site
    Plano, Texas, United States
  • 1264.3.01046 Boehringer Ingelheim Investigational Site
    San Antonio, Texas, United States
  • 1264.3.01056 Boehringer Ingelheim Investigational Site
    Norfolk, Virginia, United States
  • 1264.3.37207 Boehringer Ingelheim Investigational Site
    Harju, Estonia
  • 1264.3.37209 Boehringer Ingelheim Investigational Site
    Pärnu, Estonia
  • 1264.3.37201 Boehringer Ingelheim Investigational Site
    Tallinn, Estonia
  • 1264.3.37202 Boehringer Ingelheim Investigational Site
    Tallinn, Estonia
  • 1264.3.37208 Boehringer Ingelheim Investigational Site
    Tallinn, Estonia
  • 1264.3.37203 Boehringer Ingelheim Investigational Site
    Tallin, Estonia
  • 1264.3.37204 Boehringer Ingelheim Investigational Site
    Tallin, Estonia
  • 1264.3.37205 Boehringer Ingelheim Investigational Site
    Tallin, Estonia
  • 1264.3.37206 Boehringer Ingelheim Investigational Site
    Tartu, Estonia
  • 1264.3.37210 Boehringer Ingelheim Investigational Site
    Viljandi County, Estonia
  • 1264.3.49001 Boehringer Ingelheim Investigational Site
    Bad Lauterberg / Harz, Germany
  • 1264.3.49007 Boehringer Ingelheim Investigational Site
    Dietzenbach, Germany
  • 1264.3.49002 Boehringer Ingelheim Investigational Site
    Dortmund, Germany
  • 1264.3.49009 Boehringer Ingelheim Investigational Site
    Essen, Germany
  • 1264.3.49003 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1264.3.49012 Boehringer Ingelheim Investigational Site
    Ingelheim, Germany
  • 1264.3.49008 Boehringer Ingelheim Investigational Site
    Leipzig, Germany
  • 1264.3.49005 Boehringer Ingelheim Investigational Site
    Mainz, Germany
  • 1264.3.49010 Boehringer Ingelheim Investigational Site
    Offenbach, Germany
  • 1264.3.49004 Boehringer Ingelheim Investigational Site
    Stuhr, Germany
  • 1264.3.37105 Boehringer Ingelheim Investigational Site
    Daugavpils, Latvia
  • 1264.3.37112 Boehringer Ingelheim Investigational Site
    Daugavpils, Latvia
  • 1264.3.37113 Boehringer Ingelheim Investigational Site
    Daugavpils, Latvia
  • 1264.3.37110 Boehringer Ingelheim Investigational Site
    Jelgava, Latvia
  • 1264.3.37101 Boehringer Ingelheim Investigational Site
    Liepaja, Latvia
  • 1264.3.37106 Boehringer Ingelheim Investigational Site
    Ogre, Latvia

Showing the first 100 of 132 sites across 6 countries.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01183013
Lead sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 17, 2010
Start date
Aug 2010
Primary completion
Feb 2013
Completion
Feb 2013
Results posted
Apr 21, 2014
Last update
Oct 20, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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