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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Metformin; Sitagliptin Phosphate

Criteria

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