NCT02050074

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

January 28, 2014

Last Update Submit

October 6, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in the gut hormone glucagon-like peptide 1 (GLP-1)

    0-240 min

Study Arms (6)

Colesevelam

EXPERIMENTAL
Drug: Colesevelam

Metformin

EXPERIMENTAL
Drug: Metformin

Placebo

EXPERIMENTAL
Other: Placebo

Colesevelam + exendin (9-39)

EXPERIMENTAL
Drug: Colesevelam

Metformin + exendin (9-39)

EXPERIMENTAL
Drug: Metformin

Placebo + + exendin (9-39)

EXPERIMENTAL
Other: Placebo

Interventions

ColesevelamDRUG
ColesevelamColesevelam + exendin (9-39)
MetforminDRUG
MetforminMetformin + exendin (9-39)
PlaceboOTHER
PlaceboPlacebo + + exendin (9-39)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Division, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

Location

Related Publications (1)

  • Bahne E, Sun EWL, Young RL, Hansen M, Sonne DP, Hansen JS, Rohde U, Liou AP, Jackson ML, de Fontgalland D, Rabbitt P, Hollington P, Sposato L, Due S, Wattchow DA, Rehfeld JF, Holst JJ, Keating DJ, Vilsboll T, Knop FK. Metformin-induced glucagon-like peptide-1 secretion contributes to the actions of metformin in type 2 diabetes. JCI Insight. 2018 Dec 6;3(23):e93936. doi: 10.1172/jci.insight.93936.

    PMID: 30518693DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Colesevelam HydrochlorideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

DK(1)