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

Type 2 Diabetes Clinical Trial

— ColMetInc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050074
• Other study ID #: H-1-2013-010
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2014
• Last updated: October 6, 2014
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: De Videnskabsetiske Komiteer of the Capital Region
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Colesevelam

• Metformin

Other:
• Placebo

Locations

Country	Name	City	State
Denmark	Diabetes Research Division, Department of Medicine, Gentofte Hospital	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the gut hormone glucagon-like peptide 1 (GLP-1)		0-240 min	No