The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin in Patients With T2D
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|ClinicalTrials.gov Identifier: NCT03246451|
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glucose Metabolism Disorders||Drug: Placebo Oral Tablet Drug: Metformin Drug: Saline Drug: Exendin (9-39)||Not Applicable|
Aim: To evaluate the contribution of metformin-induced GLP-1 secretion on the glucose-lowering effect of metformin in patients with type 2 diabetes treated with metformin for 14 days. Furthermore, the investigators aim to elucidate the mechanisms by which metformin-induced GLP-1 secretion may affect glucose levels in patients with type 2 diabetes.
Fifteen patients with type 2 diabetes treated with lifestyle intervention and/or metformin as the only glucose-lowering drug will be enrolled in the study. The effect of a 14-day metformin treatment course on postprandial glucose tolerance will be examined with and without infusion of the GLP-1 receptor antagonist exendin9-39 in 15 patients with type 2 diabetes.
The double-blinded, placebo-controlled, randomised, cross-over study consists of four study days with concomitant infusions of A) placebo + placebo, B) placebo + exendin9-39, C) metformin + placebo and D) metformin + exendin9-39.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin During Meal Ingestion in Patients With T2D|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 10, 2017|
|Estimated Study Completion Date :||December 10, 2017|
Placebo Comparator: Placebo
Placebo, oral tablet in 14 days and in liquid meal.
Drug: Placebo Oral Tablet
2-4 tablets in 14 days
Metformin, oral tablet 2-4 x 500 mg in 14 days and in liquid meal.
1000-2000 mg in 14 days
Saline infusion (9mg/mL) on experimental days
9 mg/ml saline infusion during experimental days
Exendin(9-39) infusion. GLP-1 receptor antagonist used as a study tool on experimental days.
Drug: Exendin (9-39)
Infusion of GLP-1 receptor antagonist used as a tool during experimental days
- Plasma glucose [ Time Frame: Minutes 240 ]The difference between the effect of metformin on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin 9-39.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246451
|Contact: Laura S Hansen, BSc||+45 email@example.com|
|Contact: Filip K Knop, MD, PhDfirstname.lastname@example.org|
|Center for Diabetes Research||Recruiting|
|Gentofte, Copenhagen, Denmark, 2900|
|Contact: Laura S Hansen, BSc email@example.com|
|Contact: Filip K Knop, MD, PhD firstname.lastname@example.org|
|Study Director:||Filip K Knop, MD, PhD||UHGentofte, Center for Diabetes Research|