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CompletedNCT02597049AWARD-10Updated Jun 17, 2020Results posted

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus

A Phase 3 interventional study of Dulaglutide and Placebo in Type 2 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 41 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-17.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
424
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in participants with type 2 diabetes mellitus.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 424 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have type 2 diabetes mellitus (based on the World Health Organization's [WHO] diagnostic criteria)
  • Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal [GI] intolerability)

  • Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if:

    • all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and
    • >90% of prescribed daily doses were equal to the dose at randomization
  • Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization
  • Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m\^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment

Exclusion criteria

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary
  • Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
  • Had chronic or acute pancreatitis any time prior to study entry
  • Estimated glomerular filtration rate (eGFR) \<45 milliliters(mL)/minute/1.73m\^2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in
  • Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes participants with a family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfect [RET]-negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for the RET mutation)
  • Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
  • Have a serum calcitonin ≥20 picograms/mL as determined by the central laboratory at study entry
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
424 participants (actual)

Study arms

  • Experimental
    1.5 mg Dulaglutide

    1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.

    Drug: Dulaglutide · Drug: SGLT2 inhibitor · Drug: Metformin

  • Experimental
    0.75 mg Dulaglutide

    0.75 mg dulaglutide given SC once a week for 24 weeks.

    Drug: Dulaglutide · Drug: SGLT2 inhibitor · Drug: Metformin

  • Placebo comparator
    Placebo

    Placebo given SC once a week for 24 weeks.

    Drug: Placebo · Drug: SGLT2 inhibitor · Drug: Metformin

Interventions

  • DrugDulaglutide

    Administered SC

    Also known as: LY2189265

  • DrugPlacebo

    Administered SC

  • DrugSGLT2 inhibitor

    Administered orally as standard of care for type 2 diabetes

    Also known as: Canagliflozin, Dapagliflozin, Empagliflozin

  • DrugMetformin

    Administered orally as standard of care for type 2 diabetes

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

    Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.

    Time frame: Baseline, Week 24

  2. Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

    LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Percentage of Participants With HbA1c <7%

    Number of participants with an HbA1c value of \<7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.

    Time frame: 24 Weeks

  2. Change From Baseline in Body Weight at 24 Weeks

    LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis

    Time frame: Baseline, Week 24

  3. Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks

    LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).

    Time frame: Baseline, Week 24

  4. Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

    The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

    Time frame: Baseline, Week 24

  5. Change From Baseline in Fasting Glucagon at 24 Weeks

    Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).

    Time frame: Baseline, Week 24

  6. Rate of Hypoglycemic Events Adjusted Per 30 Days

    A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).

    Time frame: Baseline through 24 Weeks

  7. Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

    Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.

    Time frame: Baseline through 24 Weeks

  8. Number of Participants With Adjudicated Acute Pancreatitis Events

    The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor. A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module.

    Time frame: Baseline through 24 Weeks

  9. Number of Participants With Adjudicated Cardiovascular (CV) Events

    Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).

    Time frame: Baseline through 24 Weeks

07

Results

Posted Apr 27, 2018
Limitations and caveats
One participant was randomized into the study but did not receive study drug. This participant was not included in the efficacy or safety analysis.

Participant flow

Participant flow — Overall Study
Milestone1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Started142142140
Received at least one dose of study drug142141140
Completed135137137
Not completed753
Withdrew: Lost to follow-up032
Withdrew: Withdrawal by subject221
Withdrew: Adverse event200
Withdrew: Death200
Withdrew: Noncompliant with study visits100

Outcome measures

PrimaryChange From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
percentage of HbA1c1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)-1.34 ± 0.064-1.21 ± 0.064-0.54 ± 0.064
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <.001 · Mean difference (final values): -0.79 · 95% CI -0.97 to -0.61
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -0.66 · 95% CI -0.84 to -0.49
PrimaryChange From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)
percentage of HbA1c1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)-1.33 ± 0.063-1.19 ± 0.063-0.51 ± 0.065
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <.001 · Mean difference (final values): -0.82 · 95% CI -1.00 to -0.64
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <.001 · Mean difference (final values): -0.69 · 95% CI -0.86 to -0.51
SecondaryPercentage of Participants With HbA1c <7%

Number of participants with an HbA1c value of \<7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.

Time frame:
24 Weeks
Reported as:
Number · percentage of participants
Percentage of Participants With HbA1c <7%
percentage of participants1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Treatment-regimen Estimand71.2160.4531.58
Efficacy Estimand71.5461.8332.52
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Regression, Logistic · p = < .001
  • 0.75 mg Dulaglutide vs Placebo · Regression, Logistic · p = < .001
  • 1.5 mg Dulaglutide vs Placebo · Regression, Logistic · p = < .001
  • 0.75 mg Dulaglutide vs Placebo · Regression, Logistic · p = < .001
SecondaryChange From Baseline in Body Weight at 24 Weeks

LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · kilograms (kg)
Change From Baseline in Body Weight at 24 Weeks
kilograms (kg)1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Treatment-regimen Estimand-3.1 ± 0.30-2.6 ± 0.30-2.1 ± 0.30
Efficacy Estimand-3.1 ± 0.30-2.6 ± 0.30-2.3 ± 0.31
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = 0.027 · Mean difference (final values): -0.9 · 95% CI -1.8 to -0.1
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = 0.264 · Mean difference (final values): -0.5 · 95% CI -1.3 to 0.4
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = 0.059 · Mean difference (final values): -0.8 · 95% CI -1.7 to 0.0
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = 0.435 · Mean difference (final values): -0.3 · 95% CI -1.2 to 0.5
SecondaryChange From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks

LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · milligram/deciliter (mg/dL)
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks
milligram/deciliter (mg/dL)1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Treatment-regimen Estimand-31.6 ± 2.17-26.5 ± 2.18-6.9 ± 2.21
Efficacy Estimand-31.9 ± 2.11-26.0 ± 2.12-5.3 ± 2.21
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · ANCOVA · p = < .001 · Mean difference (final values): -24.7 · 95% CI -30.8 to -18.6
  • 0.75 mg Dulaglutide vs Placebo · ANCOVA · p = <0.001 (Test was not controlled for type I error.) · Mean difference (final values): -19.6 · 95% CI -25.7 to -13.5
  • 1.5 mg Dulaglutide vs Placebo · ANCOVA · p = <0.001 (Test was not controlled for type I error.) · Mean difference (final values): -26.6 · 95% CI -32.7 to -20.6
  • 0.75 mg Dulaglutide vs Placebo · ANCOVA · p = <0.001 (Test was not controlled for type I error.) · Mean difference (final values): -20.7 · 95% CI -26.7 to -14.6
SecondaryChange From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · mg/dL
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks
mg/dL1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Pre-morning Morning Meal-27.8 ± 2.13-23.2 ± 2.17-8.1 ± 2.14
2-Hour Postprandial Morning Meal-44.6 ± 3.31-41.1 ± 3.30-20.1 ± 3.33
Pre-Mid Day Meal-26.0 ± 2.91-22.0 ± 2.94-7.7 ± 2.93
2-Hour Postprandial Mid Day Meal-31.8 ± 3.47-25.5 ± 3.47-12.8 ± 3.53
Pre-Evening Meal-30.3 ± 2.85-30.1 ± 2.93-7.5 ± 2.91
2-Hour Postprandial Evening Meal-36.0 ± 3.30-30.6 ± 3.31-13.9 ± 3.38
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -19.7 · 95% CI -25.7 to -13.8
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -15.2 · 95% CI -21.2 to -9.2
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -24.5 · 95% CI -33.8 to -15.3
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -21.1 · 95% CI -30.3 to -11.8
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -18.3 · 95% CI -26.4 to -10.2
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -14.3 · 95% CI -22.5 to -6.2
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -19.0 · 95% CI -28.8 to -9.3
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = 0.010 · Mean difference (final values): -12.8 · 95% CI -22.5 to -3.1
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -22.7 · 95% CI -30.7 to -14.7
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -22.5 · 95% CI -30.7 to -14.4
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -22.1 · 95% CI -31.4 to -12.9
  • 0.75 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = < .001 · Mean difference (final values): -16.7 · 95% CI -26.0 to -7.4
SecondaryChange From Baseline in Fasting Glucagon at 24 Weeks

Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).

Time frame:
Baseline, Week 24
Reported as:
Least squares mean · picomole per liter (pmol/L)
Change From Baseline in Fasting Glucagon at 24 Weeks
picomole per liter (pmol/L)1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Treatment-regimen Estimand-2.1 ± 0.39-1.5 ± 0.39-0.9 ± 0.40
Efficacy Estimand-2.2 ± 0.39-1.4 ± 0.39-0.9 ± 0.41
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · ANCOVA · p = 0.032 · Mean difference (final values): -1.2 · 95% CI -2.3 to -0.1
  • 0.75 mg Dulaglutide vs Placebo · ANCOVA · p = 0.273 · Mean difference (final values): -0.6 · 95% CI -1.7 to 0.5
  • 1.5 mg Dulaglutide vs Placebo · ANCOVA · p = 0.023 · Mean difference (final values): -1.3 · 95% CI -2.4 to -0.2
  • 0.75 mg Dulaglutide vs Placebo · ANCOVA · p = 0.320 · Mean difference (final values): -0.6 · 95% CI -1.7 to 0.6
SecondaryRate of Hypoglycemic Events Adjusted Per 30 Days

A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).

Time frame:
Baseline through 24 Weeks
Reported as:
Mean · Number of events/participant/30 days
Rate of Hypoglycemic Events Adjusted Per 30 Days
Number of events/participant/30 days1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Total Hypoglycemia0.026 ± 0.18270.022 ± 0.13750.017 ± 0.1320
Documented Symptomatic Hypoglycemia0.013 ± 0.14060.013 ± 0.10300.010 ± 0.0893
Asymptomatic Hypoglycemia0.013 ± 0.11800.008 ± 0.06390.006 ± 0.0540
Probable Symptomatic0.000 ± 0.00000.001 ± 0.01520.001 ± 0.0147
Relative Hypoglycemia0.003 ± 0.03110.001 ± 0.01500.005 ± 0.0493
Nocturnal Hypoglycemia0.002 ± 0.02880.009 ± 0.08210.000 ± 0.0000
SecondaryNumber of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.

Time frame:
Baseline through 24 Weeks
Reported as:
Count of participants · Participants
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
Participants1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia032
SecondaryNumber of Participants With Adjudicated Acute Pancreatitis Events

The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor. A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module.

Time frame:
Baseline through 24 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Adjudicated Acute Pancreatitis Events
Participants1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Number of Participants With Adjudicated Acute Pancreatitis Events000
SecondaryNumber of Participants With Adjudicated Cardiovascular (CV) Events

Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).

Time frame:
Baseline through 24 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Adjudicated Cardiovascular (CV) Events
Participants1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Any CV Event003
Fatal CV Event000
Non-fatal CV Event003

Adverse events

Collected over Baseline to end of study (up to 24 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1.5 mg Dulaglutide2/142 (1.4%)5/142 (3.5%)43/142 (30.3%)
0.75 mg Dulaglutide0/141 (0%)3/141 (2.1%)34/141 (24.1%)
Placebo0/140 (0%)5/140 (3.6%)29/140 (20.7%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
Event1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Endometrial cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/650/720/74
Endometrial sarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/650/720/74
Angina unstableCardiac disorders0/1420/1412/140
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/770/690/66
Atrial fibrillationCardiac disorders0/1420/1411/140
Atrial tachycardiaCardiac disorders0/1420/1411/140
Myocardial infarctionCardiac disorders0/1420/1411/140
SepsisInfections and infestations0/1420/1411/140
InjuryInjury, poisoning and procedural complications0/1420/1411/140
Gastrointestinal haemorrhageGastrointestinal disorders0/1421/1410/140
Most frequent other events
Most frequent other events
Event1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
NauseaGastrointestinal disorders21/1427/1415/140
DiarrhoeaGastrointestinal disorders8/14214/1414/140
HeadacheNervous system disorders8/1425/14113/140
Back painMusculoskeletal and connective tissue disorders13/14212/14110/140
Viral upper respiratory tract infectionInfections and infestations9/1428/14111/140

Baseline characteristics

All randomized participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)1.5 mg Dulaglutide0.75 mg DulaglutidePlaceboTotal
Mean56.17 ± 9.2658.55 ± 9.1457.10 ± 9.5957.27 ± 9.36
Sex: Female, Male
Sex: Female, Male(Participants)1.5 mg Dulaglutide0.75 mg DulaglutidePlaceboTotal
Female657274211
Male776966212
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)1.5 mg Dulaglutide0.75 mg DulaglutidePlaceboTotal
Hispanic or Latino514444139
Not Hispanic or Latino909794281
Unknown or Not Reported1023
Race (NIH/OMB)
Race (NIH/OMB)(Participants)1.5 mg Dulaglutide0.75 mg DulaglutidePlaceboTotal
American Indian or Alaska Native1247
Asian0101
Native Hawaiian or Other Pacific Islander0000
Black or African American33612
White127127124378
More than one race118625
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)1.5 mg Dulaglutide0.75 mg DulaglutidePlaceboTotal
Austria911929
Hungary19191957
United States30302888
Czechia25232573
Mexico27282883
Israel66618
Germany12111033
Spain14131542
Baseline Mean Hemoglobin A1c (HbA1c) Treatment-Regimen Estimand
Baseline Mean Hemoglobin A1c (HbA1c) Treatment-Regimen Estimand(percentage of HbA1c)1.5 mg Dulaglutide0.75 mg DulaglutidePlaceboTotal
Mean8.04 ± 0.668.04 ± 0.618.05 ± 0.668.04 ± 0.64
08

Study locations

41 sites
  • Medical Group of Encino
    Encino, California 91436, United States
  • National Research Institute
    Huntington Park, California 90255, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • New Horizon Research Center
    Miami, Florida 33175, United States
  • Metabolic Research Institute Inc.
    West Palm Beach, Florida 33401, United States
  • Cotton O'Neil Diabetes and Endocrinology Center
    Topeka, Kansas 66606, United States
  • JCMG Clinical Research
    Jefferson City, Missouri 65109, United States
  • Grand Street Medical PC
    Brooklyn, New York 11211, United States
  • Diabetes & Endocrinology Consultants PC
    Morehead City, North Carolina 28557, United States
  • PMG Research of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • Dallas Diabetes Endocrine Center
    Dallas, Texas 75230, United States
  • Galenos Research
    Dallas, Texas 75251, United States
  • Endeavor Clinical Trials
    San Antonio, Texas 78229, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Saint Stefan Ob Stainz, 8511, Austria
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    Steyr, 4400, Austria
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    Vienna, 1030, Austria
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    Brandys Nad Labem-Stara Bolesl, 25001, Czechia
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    Holešov, 769 01, Czechia
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    Krnov, 79401, Czechia
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    Pardubice, 53002, Czechia
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    Prague, 149 00, Czechia
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    Prague, 181 00, Czechia
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    Münster, 48145, Germany
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    Oldenburg, 23758, Germany
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    Budapest, 1023, Hungary
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    Budapest, 1042, Hungary
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    Debrecen, 4043, Hungary
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    Nagykanizsa, 8800, Hungary
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    Haifa, 3299001, Israel
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    Holon, 5822012, Israel
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    Jerusalem, 911200, Israel
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    Monterrey, 64460, Mexico
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    Monterrey, 64620, Mexico
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    Zapopan, 45116, Mexico
  • Centro de Endocrinologia y Nutricion
    Caguas, 00725, Puerto Rico
  • Manati Medical Center
    Manati, 00674, Puerto Rico
  • Centro de Endocrinologia del Este
    Yabucoa, 00767, Puerto Rico
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Alicante, 03004, Spain
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    Málaga, 29006, Spain
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    Seville, 41003, Spain
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    Seville, 41010, Spain
09

References and documents

Publications

  • Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x. PubMed 36894938 ↗
  • Ludvik B, Frias JP, Tinahones FJ, Wainstein J, Jiang H, Robertson KE, Garcia-Perez LE, Woodward DB, Milicevic Z. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 May;6(5):370-381. doi: 10.1016/S2213-8587(18)30023-8. Epub 2018 Feb 23. PubMed 29483060 ↗

Study documents

  • Study protocol · Aug 21, 2015
  • Study protocol · Mar 28, 2016
  • Statistical analysis plan · Apr 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2015, a primary completion of Feb 2017 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2018, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2015
First posted
Nov 4, 2015
Start
Nov 2015
Primary completionActual
Feb 2017
CompletionActual
Feb 2017
Results first posted
Apr 27, 2018
Last update
Jun 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02597049
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 4, 2015
Start date
Nov 2015
Primary completion
Feb 2017
Completion
Feb 2017
Results posted
Apr 27, 2018
Last update
Jun 17, 2020

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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