Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: BIAsp 30 twice daily + sitagliptin + metformin: Drug: biphasic insulin aspart 30. BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.
Drug
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
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/m2 Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial No Upper age limit Specified
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 physicianâ??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 physicians 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1cTimepoint: Change from baseline in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventsTimepoint: Weeks 0-24 ;Change from baseline in fasting plasma glucoseTimepoint: Week 0, week 24 ;Change from baseline in Patient Reported Outcome by use of the Treatment Related Impact Measure - DiabetesTimepoint: Week 0, week 24;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.Timepoint: Weeks 0-24;Prandial plasma glucose (PPG) increments at each meal (breakfast, lunch and dinner) and overall mean increment.Timepoint: After 24 weeks of treatment;Responder for HbA1c, proportion of subjects achieving pre-defined HbA1c targets.Timepoint: After 24 weeks of treatment | — |
Countries
Argentina, Australia, Brazil, Greece, India, Malaysia, Republic of Korea, Thailand, Turkey
Contacts
Public ContactMr Avik Kumar Gosh
Novo Nordisk India Private Ltd.
Outcome results
None listed