type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject) 2. Male or female, age = 18 years 3. Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1 4. Treatment with at least 1000 mg metformin per day for at least 3 months prior to Visit 1 5. Subject is insulin-naïve (short-term insulin treatment of up to 14 days is allowed) 6. Subject is DPP-4 inhibitor-naïve 7. HbA_1c 7.5-10.0 % (both inclusive) by central laboratory analysis 8. Body Mass Index (BMI) = 45.0 kg/m^2 9. Able and willing to administer subcutaneous injections every day 10. Able and willing to perform mandatory SMPG measurements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any contraindication to insulin detemir or sitagliptin according to the local labelling 2. Known or suspected allergy or intolerance to any of the trial products or related products 3. Previous participation in this trial (participation is defined as randomised) 4. Treatment with thiazolidinedione (TZD) or GLP-1 analogues within 2 months prior to Visit 1 5. Cardiac disease, within the last 12 months prior to Visit 1, defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction 6. Severe hypertension, systolic blood pressure = 180 mm Hg or diastolic blood pressure = 100 mm Hg, after 5 minutes rest in the sitting position 7. Anticipated change of dose of any systemic treatment with products, which in the Investigator’s opinion could interfere with glucose metabolism (e.g. systemic corticosteroids) 8. Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the Investigator’s opinion may confound the results of the trial or pose additional risk in administering trial product(s) 9. Impaired hepatic function as indicated by aspartate aminotransferase (ASAT/SGOT) or alanine aminotransferase (ALAT/SGPT) > 2.5 times the upper normal range (one re-test within one week is permitted. Last sample will be conclusive.) 10. Impaired renal function as indicated by serum creatinine levels = 126 µmol/L (1.43 mg/dL) for males or = 111 µmol/L (1.26 mg/dL) for females or glomerular filtration rate below 60 mL/min, calculated by the Cockroft & Gault formula and according to local practise for metformin use (one re-test within a week is permitted. Last sample will be conclusive.) 11. Proliferative retinopathy or macular oedema requiring acute treatment 12. Female of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) 13. Anticipated lifestyle changes (eating, exercise, sleeping pattern) during the study, e.g. shiftwork 14. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write 15. Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results 16. Known or suspected abuse of alcohol, narcotics or illicit substances 17. The receipt of any investigational product within 4 weeks prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): HbA1c after 26 weeks of treatment;Main Objective: To compare glycaemic control, measured as HbA1c, of insulin detemir given once daily in combination with sitagliptin and metformin versus sitagliptin and metformin ± SU after a 26-week treatment period in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other OADs.;Secondary Objective: To assess and compare efficacy and safety of insulin detemir given once daily in combination with sitagliptin and metformin versus sitagliptin and metformin ± SU after a 26-week treatment period in terms of: • Proportion of subjects achieving: - HbA1c = 7.0% or 6.5% - HbA1c = 7.0% or 6.5% without symptomatic hypoglycaemia with a plasma glucose value < 4.0 mmol/L (< 72 mg/dL) or any single plasma glucose value < 3.1 mmol/L (56 mg/dL) in the last three months of treatment • The glycaemic control as measured by: - FPG (central laboratory values) -9-point plasma glucose profiles (self-measured) • Incidence of hypoglycaemic episodes during the trial: nocturnal (23:00-05:59) and over 24 hours • Incidence of adverse events (AEs) • Change in: - clinical and laboratory safety parameters - body weight - waist:hip circumference ratio | — |
Countries
Finland, France, Hungary, Slovakia
Outcome results
None listed