The Role of Metformin and Colesevelam in Human GLP-1 Secretion (ColMetInc)

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Other: Placebo; Drug: Colesevelam; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02050074

H-1-2013-010

Details and patient eligibility

About

Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal hemoglobin
• BMI > 23kg/m2
• HbA1c <9 %
• Informed concent

Exclusion criteria

• Liver disease ( aspartate aminotransferase/alanine aminotransferase >2 × reference value)
• Chronic intestinal disease
• History of liver and / or gallbladder disease
• Nephropathy (se-creatinine >110 µM and / or albuminuria)
• Insulin or GLP-1-based antidiabetic treatment
• History of cholecystectomy or surgical resection of bowel segment
• BMI <23kg/m2 or BMI >35 kg/m2
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 6 patient groups

Colesevelam

Experimental group

Treatment:

Drug: Colesevelam

Metformin

Experimental group

Treatment:

Drug: Metformin

Placebo

Experimental group

Treatment:

Other: Placebo

Colesevelam + exendin (9-39)

Experimental group

Treatment:

Drug: Colesevelam

Metformin + exendin (9-39)

Experimental group

Treatment:

Drug: Metformin

Placebo + + exendin (9-39)

Experimental group

Treatment:

Other: Placebo