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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02050074
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : October 7, 2014
Information provided by (Responsible Party):
Morten Hansen, University Hospital, Gentofte, Copenhagen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Colesevelam Drug: Metformin Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of Metformin and Colesevelam in Human GLP-1 Secretion
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Colesevelam Drug: Colesevelam
Experimental: Metformin Drug: Metformin
Experimental: Placebo Other: Placebo
Experimental: Colesevelam + exendin (9-39) Drug: Colesevelam
Experimental: Metformin + exendin (9-39) Drug: Metformin
Experimental: Placebo + + exendin (9-39) Other: Placebo

Primary Outcome Measures :
  1. Change in the gut hormone glucagon-like peptide 1 (GLP-1) [ Time Frame: 0-240 min ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02050074

Diabetes Research Division, Department of Medicine, Gentofte Hospital
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

Responsible Party: Morten Hansen, Dr., University Hospital, Gentofte, Copenhagen Identifier: NCT02050074     History of Changes
Other Study ID Numbers: H-1-2013-010
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Colesevelam Hydrochloride
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents