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CompletedNCT01519674SIT2MIXUpdated Feb 24, 2017Results posted

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

A Phase 4 interventional study of biphasic insulin aspart 30 and biphasic insulin aspart 30 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 69 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
582
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).

The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 582 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

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

Inclusion criteria

  • Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)
  • Stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
  • Stable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
  • Subject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
  • HbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other OADs)
  • Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
  • Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial

Exclusion criteria

Exclusion Criteria:

  • Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1)
  • Cardiac disease within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction
  • Severe hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1)
  • Anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
  • Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
  • Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) above 2.5 times the upper normal range, according to central laboratory reference ranges
  • Impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft \& Gault formula and according to local practise for metformin use
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
582 participants (actual)

Study arms

  • Active comparator
    BIAsp 30 BID + sitagliptin + metformin

    Drug: biphasic insulin aspart 30 · Drug: sitagliptin · Drug: metformin

  • Active comparator
    BIAsp 30 BID + metformin

    Drug: biphasic insulin aspart 30 · Drug: metformin

  • Active comparator
    BIAsp 30 OD + sitagliptin + metformin

    Drug: biphasic insulin aspart 30 · Drug: sitagliptin · Drug: metformin

Interventions

  • Drugbiphasic insulin aspart 30

    BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

  • Drugbiphasic insulin aspart 30

    BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.

  • Drugsitagliptin

    Subjects will continue on their pre-trial sitagliptin treatment.

  • Drugmetformin

    Subjects will continue on their pre-trial metformin treatment.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin)

    Estimated mean change from baseline in HbA1c after 24 weeks of treatment.

    Time frame: Week 0 to Week 24

Secondary outcomes

  1. Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)

    Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment

    Time frame: After 24 weeks of treatment

  2. Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)

    Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.

    Time frame: After 24 weeks of treatment

  3. Change From Baseline in Fasting Plasma Glucose (FPG)

    Estimated mean change from baseline in fasting plasma glucose (FPG)

    Time frame: Week 0 to Week 24

  4. Prandial Plasma Glucose (PPG) Increments at Breakfast

    Estimated mean post prandial increments at breakfast after 24 weeks of treatment.

    Time frame: After 24 weeks of treatment

  5. Prandial Plasma Glucose (PPG) Increments at Lunch.

    Estimated mean post prandial increments at lunch after 24 weeks of treatment.

    Time frame: After 24 weeks of treatment

  6. Prandial Plasma Glucose (PPG) Increments at Dinner.

    Estimated mean post prandial increments at dinner after 24 weeks of treatment.

    Time frame: After 24 weeks of treatment

  7. Prandial Plasma Glucose (PPG) Overall Mean Increment.

    Estimated overall mean post prandial increment after 24 weeks of treatment.

    Time frame: After 24 weeks of treatment

  8. Adverse Events (AEs)

    Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

    Time frame: Week 0 to Week 24

  9. Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.

    Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values \< 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) \< 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.

    Time frame: Week 0 to Week 24

  10. Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.

    Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction.

    Time frame: Week 0 to Week 24

07

Results

Posted Nov 10, 2014

Participant flow

The trial was conducted at 60 sites in 10 countries as follows: Argentina (6); Australia (2); Brazil (4); Greece (5); India (17); Malaysia (3); Portugal (6); Republic of Korea (7); Thailand (5); Turkey (5)

Participant flow — Overall Study
MilestoneBID + MetBID + Sita + MetOD + Sita + Met
Started194195193
Exposed192193190
Completed173182181
Not completed211312
Withdrew: Adverse event330
Withdrew: Lack of efficacy111
Withdrew: Protocol violation031
Withdrew: Withdrawal criteria727
Withdrew: Unsclassified1043

Outcome measures

PrimaryChange From Baseline in HbA1c (Glycosylated Haemoglobin)

Estimated mean change from baseline in HbA1c after 24 weeks of treatment.

Time frame:
Week 0 to Week 24
Reported as:
Least squares mean · percentage of glycosylated haemoglobin
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
percentage of glycosylated haemoglobinBID + MetBID + Sita + MetOD + Sita + Met
Change From Baseline in HbA1c (Glycosylated Haemoglobin)-1.27 ± 0.07-1.51 ± 0.07-1.15 ± 0.07
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.011 (No corrections for multiplicity were performed.) · Estimated treatment difference: 0.24 · 95% CI 0.06 to 0.43
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.231 · Estimated treatment difference: -0.11 · 95% CI -0.30 to 0.07
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = <0.001 · Estimated treatment difference: -0.36 · 95% CI -0.54 to -0.17
SecondaryResponder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)

Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment

Time frame:
After 24 weeks of treatment
Reported as:
Number · percentage (%) of subjects
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
percentage (%) of subjectsBID + MetBID + Sita + MetOD + Sita + Met
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)49.759.846.5
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Logistic · p = 0.022 · Odds ratio (or): 0.60 · 95% CI 0.39 to 0.93
  • BID + Met vs OD + Sita + Met · Regression, Logistic · p = 0.618 · Odds ratio (or): 1.12 · 95% CI 0.73 to 1.71
  • BID + Sita + Met vs OD + Sita + Met · Regression, Logistic · p = 0.005 · Odds ratio (or): 1.85 · 95% CI 1.20 to 2.85
SecondaryResponder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)

Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.

Time frame:
After 24 weeks of treatment
Reported as:
Number · percentage (%) of subjects
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
percentage (%) of subjectsBID + MetBID + Sita + MetOD + Sita + Met
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)30.640.725.1
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Logistic · p = 0.020 · Odds ratio (or): 0.59 · 95% CI 0.38 to 0.92
  • BID + Met vs OD + Sita + Met · Regression, Logistic · p = 0.286 · Odds ratio (or): 1.29 · 95% CI 0.81 to 2.07
  • BID + Sita + Met vs OD + Sita + Met · Regression, Logistic · p = <0.001 · Odds ratio (or): 2.20 · 95% CI 1.39 to 3.47
SecondaryChange From Baseline in Fasting Plasma Glucose (FPG)

Estimated mean change from baseline in fasting plasma glucose (FPG)

Time frame:
Week 0 to Week 24
Reported as:
Least squares mean · mmol/L
Change From Baseline in Fasting Plasma Glucose (FPG)
mmol/LBID + MetBID + Sita + MetOD + Sita + Met
Change From Baseline in Fasting Plasma Glucose (FPG)-1.90 ± 0.14-2.03 ± 0.14-1.96 ± 0.14
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.520 · Estimated treatment difference: 0.13 · 95% CI -0.26 to 0.52
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.788 · Estimated treatment difference: 0.05 · 95% CI -0.34 to 0.45
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = 0.708 · Estimated treatment difference: -0.07 · 95% CI -0.46 to 0.31
SecondaryPrandial Plasma Glucose (PPG) Increments at Breakfast

Estimated mean post prandial increments at breakfast after 24 weeks of treatment.

Time frame:
After 24 weeks of treatment
Reported as:
Least squares mean · mmol/L
Prandial Plasma Glucose (PPG) Increments at Breakfast
mmol/LBID + MetBID + Sita + MetOD + Sita + Met
Prandial Plasma Glucose (PPG) Increments at Breakfast2.01 ± 0.191.73 ± 0.192.89 ± 0.19
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.291 · Estimated treatment difference: 0.28 · 95% CI -0.24 to 0.81
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.001 · Estimated treatment difference: -0.88 · 95% CI -1.41 to -0.35
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = <0.001 · Estimated treatment difference: -1.16 · 95% CI -1.69 to -0.64
SecondaryPrandial Plasma Glucose (PPG) Increments at Lunch.

Estimated mean post prandial increments at lunch after 24 weeks of treatment.

Time frame:
After 24 weeks of treatment
Reported as:
Least squares mean · mmol/L
Prandial Plasma Glucose (PPG) Increments at Lunch.
mmol/LBID + MetBID + Sita + MetOD + Sita + Met
Prandial Plasma Glucose (PPG) Increments at Lunch.3.05 ± 0.222.19 ± 0.212.52 ± 0.21
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.005 · Estimated treatment difference: 0.85 · 95% CI 0.26 to 1.45
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.085 · Estimated treatment difference: 0.52 · 95% CI -0.07 to 1.12
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = 0.275 · Estimated treatment difference: -0.33 · 95% CI -0.92 to 0.26
SecondaryPrandial Plasma Glucose (PPG) Increments at Dinner.

Estimated mean post prandial increments at dinner after 24 weeks of treatment.

Time frame:
After 24 weeks of treatment
Reported as:
Least squares mean · mmol/L
Prandial Plasma Glucose (PPG) Increments at Dinner.
mmol/LBID + MetBID + Sita + MetOD + Sita + Met
Prandial Plasma Glucose (PPG) Increments at Dinner.0.89 ± 0.211.01 ± 0.200.17 ± 0.21
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.674 · Estimated treatment difference: -0.12 · 95% CI -0.70 to 0.45
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.015 · Estimated treatment difference: 0.72 · 95% CI 0.14 to 1.30
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = 0.004 · Estimated treatment difference: 0.84 · 95% CI 0.27 to 1.41
SecondaryPrandial Plasma Glucose (PPG) Overall Mean Increment.

Estimated overall mean post prandial increment after 24 weeks of treatment.

Time frame:
After 24 weeks of treatment
Reported as:
Least squares mean · mmol/L
Prandial Plasma Glucose (PPG) Overall Mean Increment.
mmol/LBID + MetBID + Sita + MetOD + Sita + Met
Prandial Plasma Glucose (PPG) Overall Mean Increment.1.97 ± 0.121.66 ± 0.121.88 ± 0.12
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.080 · Estimated treatment difference: 0.31 · 95% CI -0.04 to 0.65
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.613 · Estimated treatment difference: 0.09 · 95% CI -0.26 to 0.43
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = 0.213 · Estimated treatment difference: -0.22 · 95% CI -0.56 to 0.13
SecondaryAdverse Events (AEs)

Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

Time frame:
Week 0 to Week 24
Reported as:
Number · Events/100 years of patient exposure
Adverse Events (AEs)
Events/100 years of patient exposureBID + MetBID + Sita + MetOD + Sita + Met
All treatment emergent adverse events262.2209.9281.2
Serious adverse events8.45.810.5
Severe adverse events6.010.57.0
Moderate adverse events71.074.679.7
Mild adverse events185.2124.8194.5
Fatal adverse events000
SecondaryNumber of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.

Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values \< 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) \< 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.

Time frame:
Week 0 to Week 24
Reported as:
Number · episodes
Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.
episodesBID + MetBID + Sita + MetOD + Sita + Met
Diurnal (ADA)515440249
Nocturnal (ADA)685463
Diurnal (additional minor)16311271
Nocturnal (additional minor)211423
SecondaryChange From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.

Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction.

Time frame:
Week 0 to Week 24
Reported as:
Least squares mean · scores
Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
scoresBID + MetBID + Sita + MetOD + Sita + Met
Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.6.22 ± 0.825.93 ± 0.816.20 ± 0.81
Statistical analysis
  • BID + Met vs BID + Sita + Met · Regression, Linear · p = 0.800 · Estimated treatment difference: 0.29 · 95% CI -1.97 to 2.56
  • BID + Met vs OD + Sita + Met · Regression, Linear · p = 0.989 · Estimated treatment difference: 0.02 · 95% CI -2.26 to 2.29
  • BID + Sita + Met vs OD + Sita + Met · Regression, Linear · p = 0.809 · Estimated treatment difference: -0.28 · 95% CI -2.52 to 1.97

Adverse events

Collected over Adverse events were captured the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BID + Met—7/192 (3.6%)30/192 (15.6%)
BID + Sita + Met—5/193 (2.6%)25/193 (13%)
OD + Sita + Met—4/190 (2.1%)32/190 (16.8%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventBID + MetBID + Sita + MetOD + Sita + Met
PyrexiaGeneral disorders0/1920/1931/190
GastroenteritisInfections and infestations0/1920/1931/190
HypoglycaemiaMetabolism and nutrition disorders1/1921/1931/190
MyalgiaMusculoskeletal and connective tissue disorders0/1920/1931/190
Haemorrhagic strokeNervous system disorders0/1920/1931/190
Hypoglycaemic unconsciousnessNervous system disorders0/1920/1931/190
AnaemiaBlood and lymphatic system disorders1/1920/1930/190
Supraventricular tachycardiaCardiac disorders1/1920/1930/190
Drug hypersensitivityImmune system disorders1/1920/1930/190
Liver abscessInfections and infestations1/1920/1930/190
Most frequent other events
Most frequent other events
EventBID + MetBID + Sita + MetOD + Sita + Met
InfluenzaInfections and infestations11/1925/19310/190
NasopharyngitisInfections and infestations9/19211/1938/190
HeadacheNervous system disorders7/19211/1938/190
DiarrhoeaGastrointestinal disorders8/1921/19310/190

Baseline characteristics

Age, Continuous
Age, Continuous(years)BID + MetBID + Sita + MetOD + Sita + MetTotal
Mean54.8 ± 9.556.3 ± 10.255.7 ± 10.455.6 ± 10.0
Gender
Gender(Participants)BID + MetBID + Sita + MetOD + Sita + MetTotal
Female8310197281
Male1119496301
Body Weight
Body Weight(kg)BID + MetBID + Sita + MetOD + Sita + MetTotal
Mean79.4 ± 15.878.3 ± 16.177.5 ± 16.878.4 ± 16.2
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)BID + MetBID + Sita + MetOD + Sita + MetTotal
Mean29.3 ± 4.329.4 ± 4.529.4 ± 5.029.4 ± 4.6
Glycosylated haemoglobin (HbA1c)
Glycosylated haemoglobin (HbA1c)(Percent (%) glycosylated haemoglobin)BID + MetBID + Sita + MetOD + Sita + MetTotal
Mean8.4 ± 0.88.4 ± 0.88.4 ± 0.88.4 ± 0.8
Fasting plasma glucose (FPG)
Fasting plasma glucose (FPG)(mmol/L)BID + MetBID + Sita + MetOD + Sita + MetTotal
Mean8.9 ± 2.29.3 ± 2.88.7 ± 2.79.0 ± 2.6
08

Study locations

69 sites
  • Novo Nordisk Investigational Site
    Buenos Aires, B1704ETD, Argentina
  • Novo Nordisk Investigational Site
    Buenos Aires, C1250AAN, Argentina
  • Novo Nordisk Investigational Site
    Caba, C1179AAB, Argentina
  • Novo Nordisk Investigational Site
    Caba, C1440AAD, Argentina
  • Novo Nordisk Investigational Site
    Mar del Plata, B7600FZN, Argentina
  • Novo Nordisk Investigational Site
    Morón, B1708IFF, Argentina
  • Novo Nordisk Investigational Site
    Broadmeadow, New South Wales 2292, Australia
  • Novo Nordisk Investigational Site
    Coffs Harbour, New South Wales 2450, Australia
  • Novo Nordisk Investigational Site
    São Paulo, Sao Paulo 01244-030, Brazil
  • Novo Nordisk Investigational Site
    Brasília, 71625-009, Brazil
  • Novo Nordisk Investigational Site
    Curitiba, 80810-040, Brazil
  • Novo Nordisk Investigational Site
    Fortaleza, 60430-350, Brazil
  • Novo Nordisk Investigational Site
    Porto Alegre, 90035-170, Brazil
  • Novo Nordisk Investigational Site
    Alexandroupolis, GR-68100, Greece
  • Novo Nordisk Investigational Site
    Athens, 151 23, Greece
  • Novo Nordisk Investigational Site
    Athens, GR-17562, Greece
  • Novo Nordisk Investigational Site
    Thessaloniki, GR-54642, Greece
  • Novo Nordisk Investigational Site
    Thessaloniki, GR-57001, Greece
  • Novo Nordisk Investigational Site
    Thessaloniki, GR-57010, Greece
  • Novo Nordisk Investigational Site
    Hyderabad, Andhra Pradesh 500003, India
  • Novo Nordisk Investigational Site
    Hyderabad, Andhra Pradesh 500034, India
  • Novo Nordisk Investigational Site
    Hyderabad, Andhra Pradesh 500082, India
  • Novo Nordisk Investigational Site
    Visakhapatnam, Andhra Pradesh 530002, India
  • Novo Nordisk Investigational Site
    Ahmedabad, Gujarat 380006, India
  • Novo Nordisk Investigational Site
    Ahmedabad, Gujarat 380016, India
  • Novo Nordisk Investigational Site
    Bangalore, Karnataka 560 017, India
  • Novo Nordisk Investigational Site
    Bangalore, Karnataka 560002, India
  • Novo Nordisk Investigational Site
    Bangalore, Karnataka 560043, India
  • Novo Nordisk Investigational Site
    Bangalore, Karnataka 560092, India
  • Novo Nordisk Investigational Site
    Calicut, Kerala 673016, India
  • Novo Nordisk Investigational Site
    Trivandrum, Kerala 695607, India
  • Novo Nordisk Investigational Site
    Nagpur, Maharashtra 440010, India
  • Novo Nordisk Investigational Site
    Amritsar, Punjab 143001, India
  • Novo Nordisk Investigational Site
    Chennai, Tamil Nadu 600003, India
  • Novo Nordisk Investigational Site
    Chennai, Tamil Nadu 600006, India
  • Novo Nordisk Investigational Site
    Chennai, Tamil Nadu 600040, India
  • Novo Nordisk Investigational Site
    Coimbatore, Tamil Nadu 641009, India
  • Novo Nordisk Investigational Site
    Trichy, Tamil Nadu 620018, India
  • Novo Nordisk Investigational Site
    Kanpur, Uttar Pradesh 208005, India
  • Novo Nordisk Investigational Site
    Noida, Uttar Pradesh 201301, India
  • Novo Nordisk Investigational Site
    Varanasi, Uttar Pradesh 221105, India
  • Novo Nordisk Investigational Site
    Kolkata, West Bengal 700019, India
  • Novo Nordisk Investigational Site
    Kolkata, West Bengal 700038, India
  • Novo Nordisk Investigational Site
    New Delhi, 110001, India
  • Novo Nordisk Investigational Site
    Goyang, 10380, Korea, Republic of
  • Novo Nordisk Investigational Site
    Jeonju, 561-712, Korea, Republic of
  • Novo Nordisk Investigational Site
    Pusan, 602-739, Korea, Republic of
  • Novo Nordisk Investigational Site
    Pyungchon-Dong 896, Dongan-Gu, 431-796, Korea, Republic of
  • Novo Nordisk Investigational Site
    Seoul, 03080, Korea, Republic of
  • Novo Nordisk Investigational Site
    Seoul, 150-713, Korea, Republic of
  • Novo Nordisk Investigational Site
    Suwon, 16247, Korea, Republic of
  • Novo Nordisk Investigational Site
    Ulsan, 682-060, Korea, Republic of
  • Novo Nordisk Investigational Site
    Penang, 10459, Malaysia
  • Novo Nordisk Investigational Site
    Seremban, 70300, Malaysia
  • Novo Nordisk Investigational Site
    Coimbra, 3000-561, Portugal
  • Novo Nordisk Investigational Site
    Lisboa, 1250-230, Portugal
  • Novo Nordisk Investigational Site
    Lisboa, 1500-650, Portugal
  • Novo Nordisk Investigational Site
    Lisboa, 1649-035, Portugal
  • Novo Nordisk Investigational Site
    Matosinhos, 4464-513, Portugal
  • Novo Nordisk Investigational Site
    Porto, 4200-319, Portugal
  • Novo Nordisk Investigational Site
    Bangkok, 10330, Thailand
  • Novo Nordisk Investigational Site
    Bangkok, 10400, Thailand
  • Novo Nordisk Investigational Site
    Chiang Mai, 50200, Thailand
  • Novo Nordisk Investigational Site
    Khon Kaen, 40002, Thailand
  • Novo Nordisk Investigational Site
    Antalya, 07058, Turkey
  • Novo Nordisk Investigational Site
    Istanbul, 34371, Turkey
  • Novo Nordisk Investigational Site
    Istanbul, 34718, Turkey
  • Novo Nordisk Investigational Site
    Istanbul, 34722, Turkey
  • Novo Nordisk Investigational Site
    Istanbul, 34890, Turkey
09

References and documents

Publications

  • Linjawi S, Sothiratnam R, Sari R, Andersen H, Hiort LC, Rao P. The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial. Prim Care Diabetes. 2015 Oct;9(5):370-6. doi: 10.1016/j.pcd.2014.11.001. Epub 2014 Dec 3. PubMed 25488587 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01519674
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 27, 2012
Start date
Jun 2012
Primary completion
Oct 2013
Completion
Oct 2013
Results posted
Nov 10, 2014
Last update
Feb 24, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

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

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