Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

March 31, 2014

Conditions
Type 2 Diabetes
Interventions
OTHER

Mixed meal test

Mixed meal test were performed in the morning after an overnight fast. The standardized mixed meal was composed of 2 eggs (100 g), 1 slice (50 g) of whole grain rye bread, 1 slice (50 g) of rye flour bread, 10 g of fat-reduced margarine, 20 g of boiled ham, and 25 g of diet jam, amounting to 450 kcal, 50 % carbohydrate, 20 % protein, and 30 % fat (based on calorie count). Patients were allowed to drink tea (black or fruit-based) or de-caffeinated coffee ad libitum.

DRUG

Vildagliptin

Vildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment.

DRUG

Sitagliptin

The dosage of sitagliptin depended on the stratum defined by the background diabetes medication. In patients treated with diet and exercise (no other glucose-.lowering medication), sitagliptin was given as one 100 mg in the morning (15 minutes prior to breakfast or the test meal, on the last day of the treatment period), and a corresponding placebo tablet was administered in the evening (no temporal relation to dinner required).

DRUG

Placebo

Placebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required).

DRUG

Metformin

For patients continuing with pre-existing metformin treatment, 1000 mg film coated tablets from commercial sources. In half of the patients (stratum: metformin as background medication), metformin was administered orally twice daily at 1000 mg of active compound during of after breakfast and dinner.

OTHER

Diet and exercise

Patients treated their diabetes mellitus type 2 with diet/exercise only

Trial Locations (1)

37431

Diabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz

All Listed Sponsors
lead

Michael A. Nauck

OTHER

NCT02749032 - Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion | Biotech Hunter | Biotech Hunter