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

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00789191

Run by

Novo Nordisk A/S

People needed

222

Starts

2008-11-01

Expected to finish

2009-08-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Santa Monica, California, United States
• Novo Nordisk Investigational Site — Dunwoody, Georgia, United States
• Novo Nordisk Investigational Site — West Seneca, New York, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Norristown, Pennsylvania, United States
• Novo Nordisk Investigational Site — Chattanooga, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Coquitlam, British Columbia, Canada
• Novo Nordisk Investigational Site — New Westminster, British Columbia, Canada
• Novo Nordisk Investigational Site — St. John's, Newfoundland and Labrador, Canada
• Novo Nordisk Investigational Site — Cambridge, Ontario, Canada
• Novo Nordisk Investigational Site — Niagara Falls, Ontario, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Saint Romuald, Quebec, Canada
• Novo Nordisk Investigational Site — Sherbrooke, Quebec, Canada
• Novo Nordisk Investigational Site — Niagara Falls, Canada
• Novo Nordisk Investigational Site — Helsinki, Finland
• Novo Nordisk Investigational Site — Loimaa, Finland
• Novo Nordisk Investigational Site — Oulu, Finland
• Novo Nordisk Investigational Site — Pieksämäki, Finland
• Novo Nordisk Investigational Site — Pori, Finland
• Novo Nordisk Investigational Site — Vestavia Hills, Alabama, United States

Full record on ClinicalTrials.gov

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