The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin During Meal Ingestion in Patients With T2D
| Registry | NCT03246451 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: triple, basic science |
| Enrollment | 15 (Actual) |
| Sponsor | University Hospital, Gentofte, Copenhagen (Other); collaborators: University of Copenhagen |
| Conditions | Glucose Metabolism Disorders |
| Interventions | Placebo Oral Tablet, Metformin, Saline, Exendin (9-39) (Drug) |
| Dates | start 2017-07-01, primary completion 2017-12-10, completion 2017-12-10, first posted 2017-08-11, last updated 2018-07-09 |
| Locations | 1 site in Denmark |
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Delineation of the role of glucagon-like peptide-1 receptor signalling in the glucose-lowering effect of metformin during meal ingestion in patients with type 2 diabetes.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet | Placebo, oral tablet in 14 days and in liquid meal. |
| Metformin | Experimental | Drug: Metformin | Metformin, oral tablet 2-4 x 500 mg in 14 days and in liquid meal. |
| Saline | Experimental | Drug: Saline | Saline infusion (9mg/mL) on experimental days |
| Exendin(9-39) | Experimental | Drug: Exendin (9-39) | Exendin(9-39) infusion. GLP-1 receptor antagonist used as a study tool on experimental days. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)), with a HbA1c <58 mmol/mol. * Caucasian ethnicity * Lifestyle intervention and/or metformin monotherapy * Normal haemoglobin * Age >18 years * BMI >23 kg/m2 and <35 kg/m2 * Informed and written consent Exclusion Criteria: * Liver disease * Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery * Hypo- or hyperphosphataemia * Reduced kidney function or nephropathy * Treatment with medicine that cannot be paused for 12 hours * Intake of antibiotics two months prior to study * Hypo- or hypercalcaemia * Hypo- and hyperthyroidism * Treatment with oral anticoagulants * Active or recent malignant disease * Any treatment or condition requiring acute or sub-acute medical or surgical intervention * Lack of effective birth control in premenopausal women * Positive pregnancy test on study days in premenopausal women * Pregnancy * Women who are breastfeeding * Any condition considered incompatible with participation by the investigators * If the subjects receive any antibiotic treatment while included in the study they will be excluded
| Facility | City | Country | Status |
|---|---|---|---|
| Center for Diabetes Research | Gentofte Municipality, Copenhagen | Denmark |