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

What Was Tested

This registered phase 3 trial tested Insulin Detemir.

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.

It had two arms (groups): Comb (experimental) and Sita (active comparator).

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

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 222 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosed with type 2 diabetes for at least 6 months before trial start. Insulin-naive (short-term insulin treatment of up to 14 days is allowed). DPP-4 (dipeptidyl peptidase-4) inhibitor naive. BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2. Able and willing to take one subcutaneous injection every day.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

The Insulin Detemir group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.

It started in 2008-11 with completion listed for 2009-08.

It ran at 51 sites in United States (10), Canada (10), France (7), Finland (6), Slovakia (6) and Hungary (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (Glycosylated Haemoglobin A1c) (time frame: Week 26).

It also tracked 11 secondary outcomes, for example Change in BMI (Body Mass Index), Change in Body Weight, FPG (Fasting Plasma Glucose), Hypoglycemic Episodes, Hypoglycemic Episodes: Day Time and Hypoglycemic Episodes: Night Time.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir in 222 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Detemir compound page, all human trials.