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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: sulphonylurea; Drug: insulin detemir; Drug: sitagliptin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789191

2008-001050-40 (EudraCT Number)

NN304-3511

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Comb

Experimental group

Description:

Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment

Treatment:

Drug: sitagliptin

Drug: metformin

Drug: insulin detemir

Sita

Active Comparator group

Description:

Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment

Treatment:

Drug: sulphonylurea

Drug: sitagliptin

Drug: metformin