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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02050074

Acronym

ColMetInc

Enrollment

Registered

2014-01-30

Start date

2014-01-31

Completion date

2014-09-30

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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).

Interventions

DRUGColesevelam

DRUGMetformin

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change in the gut hormone glucagon-like peptide 1 (GLP-1)	0-240 min

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026