Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

Phase 3

Completed

Interventions: Drug: insulin detemir
Drug: sitagliptin
Drug: sulphonylurea
Drug: metformin

Brief Summary: This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.

Recruitment & Eligibility

Inclusion Criteria

Diagnosed with type 2 diabetes for at least 6 months before trial start
Treatment with at least 1000 mg metformin per day for at least 3 months
Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
DPP-4 (dipeptidyl peptidase-4) inhibitor naive
HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
Able and willing to take one subcutaneous injection every day
Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements

Exclusion Criteria

Known or suspected allergy or intolerance to any of the trial products or related products
Severe hypertension
Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
Cardiac disease, within the last 12 months
Impaired hepatic function
Impaired renal function
Proliferative retinopathy or macular oedema requiring acute treatment
Female of childbearing potential
Known or suspected abuse of alcohol, narcotics or illicit substances

Arm && Interventions

Group	Intervention	Description
Comb	insulin detemir	Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
Comb	sitagliptin	Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
Sita	sulphonylurea	Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
Comb	metformin	Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
Sita	metformin	Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
Sita	sitagliptin	Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycosylated Haemoglobin A1c)	Week 26

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%	Week 26
Change in BMI (Body Mass Index)	Week 0, Week 26
Hypoglycemic Episodes: Night Time	Weeks 0-26	Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%	Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia	Week 26	Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Hypoglycemic Episodes	Weeks 0-26	Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia	Week 26	Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
FPG (Fasting Plasma Glucose)	Week 26
Hypoglycemic Episodes: Day Time	Weeks 0-26	Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Change in Body Weight	Week 0, Week 26
Self-measured 9-point Plasma Glucose Profile	Week 26