NCT03246451

Brief Summary

Delineation of the role of glucagon-like peptide-1 receptor signalling in the glucose-lowering effect of metformin during meal ingestion in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

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

July 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2017

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

August 1, 2017

Last Update Submit

July 6, 2018

Conditions

Glucose Metabolism Disorders

Keywords

GLP-1glucagon-like peptide-1MetforminExendin(9-39)

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose

    The difference between the effect of metformin on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin 9-39.

    Minutes 240

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo, oral tablet in 14 days and in liquid meal.

Drug: Placebo Oral Tablet

Metformin

EXPERIMENTAL

Metformin, oral tablet 2-4 x 500 mg in 14 days and in liquid meal.

Drug: Metformin

Saline

EXPERIMENTAL

Saline infusion (9mg/mL) on experimental days

Drug: Saline

Exendin(9-39)

EXPERIMENTAL

Exendin(9-39) infusion. GLP-1 receptor antagonist used as a study tool on experimental days.

Drug: Exendin (9-39)

Interventions

Placebo Oral TabletDRUG

2-4 tablets in 14 days

Placebo
MetforminDRUG

1000-2000 mg in 14 days

Metformin
SalineDRUG

9 mg/ml saline infusion during experimental days

Saline
Exendin (9-39)DRUG

Infusion of GLP-1 receptor antagonist used as a tool during experimental days

Exendin(9-39)

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)), with a HbA1c \<58 mmol/mol.
  • Caucasian ethnicity
  • Lifestyle intervention and/or metformin monotherapy
  • Normal haemoglobin
  • Age \>18 years
  • BMI \>23 kg/m2 and \<35 kg/m2
  • Informed and written consent

You may not qualify if:

  • Liver disease
  • Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
  • Hypo- or hyperphosphataemia
  • Reduced kidney function or nephropathy
  • Treatment with medicine that cannot be paused for 12 hours
  • Intake of antibiotics two months prior to study
  • Hypo- or hypercalcaemia
  • Hypo- and hyperthyroidism
  • Treatment with oral anticoagulants
  • Active or recent malignant disease
  • Any treatment or condition requiring acute or sub-acute medical or surgical intervention
  • Lack of effective birth control in premenopausal women
  • Positive pregnancy test on study days in premenopausal women
  • Pregnancy
  • Women who are breastfeeding
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research

Gentofte Municipality, Copenhagen, 2900, Denmark

Location

Related Publications (1)

  • Hansen LS, Gasbjerg LS, Bronden A, Dalsgaard NB, Bahne E, Stensen S, Hellmann PH, Rehfeld JF, Hartmann B, Wewer Albrechtsen NJ, Holst JJ, Vilsboll T, Knop FK. The role of glucagon-like peptide 1 in the postprandial effects of metformin in type 2 diabetes: a randomized crossover trial. Eur J Endocrinol. 2024 Aug 5;191(2):192-203. doi: 10.1093/ejendo/lvae095.

    PMID: 39049802DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

MetforminSodium Chlorideexendin (9-39)

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Filip K Knop, MD, PhD

    UHGentofte, Center for Diabetes Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor of Science

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 11, 2017

Study Start

July 1, 2017

Primary Completion

December 10, 2017

Study Completion

December 10, 2017

Last Updated

July 9, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)