Glucose Metabolism DisordersNCT03246451
The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin in Patients With T2D
A study testing Metformin, Saline and Exendin (9-39) in people with Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Metformin, Saline and Exendin (9-39)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2017to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Any condition considered incompatible with participation by the investigators
- If the subjects receive any antibiotic treatment while included in the study they will be excluded
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research
Gentofte Municipality, Copenhagen, 2900
About this study
Official title: The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin During Meal Ingestion in Patients With T2D
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.
Read the detailed description
Aim: To evaluate the contribution of metformin-induced GLP-1 secretion on the glucose-lowering effect of metformin in patients with type 2 diabetes treated with metformin for 14 days. Furthermore, the investigators aim to elucidate the mechanisms by which metformin-induced GLP-1 secretion may affect glucose levels in patients with type 2 diabetes.
Fifteen patients with type 2 diabetes treated with lifestyle intervention and/or metformin as the only glucose-lowering drug will be enrolled in the study. The effect of a 14-day metformin treatment course on postprandial glucose tolerance will be examined with and without infusion of the GLP-1 receptor antagonist exendin9-39 in 15 patients with type 2 diabetes.
The double-blinded, placebo-controlled, randomised, cross-over study consists of four study days with concomitant infusions of A) placebo + placebo, B) placebo + exendin9-39, C) metformin + placebo and D) metformin + exendin9-39.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Placebo Oral Tablet, Metformin, Saline, Exendin (9-39)
- Keywords
- GLP-1, glucagon-like peptide-1, Metformin, Exendin(9-39)
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
2-4 tablets in 14 days
MetforminDrug
1000-2000 mg in 14 days
SalineDrug
9 mg/ml saline infusion during experimental days
Exendin (9-39)Drug
Infusion of GLP-1 receptor antagonist used as a tool during experimental days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, oral tablet in 14 days and in liquid meal. Receives: Drug: Placebo Oral Tablet |
| Metformin | Experimental | Metformin, oral tablet 2-4 x 500 mg in 14 days and in liquid meal. Receives: Drug: Metformin |
| Saline | Experimental | Saline infusion (9mg/mL) on experimental days Receives: Drug: Saline |
| Exendin(9-39) | Experimental | Exendin(9-39) infusion. GLP-1 receptor antagonist used as a study tool on experimental days. Receives: Drug: Exendin (9-39) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Minutes 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Jul 2017
- Primary completion10 Dec 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Laura Smidt Hansen, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Study director, UHGentofte, Center for Diabetes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246451
- Sponsor's protocol ID
- UHG-CFD-METEX
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39049802
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin During Meal Ingestion in Patients With T2D
- ClinicalTrials.gov ID
- NCT03246451
- Acronym / sponsor ID
- UHG-CFD-METEX
- Conditions
- Glucose Metabolism Disorders
- Keywords
- GLP-1, glucagon-like peptide-1, Metformin, Exendin(9-39)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim: To evaluate the contribution of metformin-induced GLP-1 secretion on the glucose-lowering effect of metformin in patients with type 2 diabetes treated with metformin for 14 days. Furthermore, the investigators aim to elucidate the mechanisms by which metformin-induced GLP-1 secretion may affect glucose levels in patients with type 2 diabetes.
Fifteen patients with type 2 diabetes treated with lifestyle intervention and/or metformin as the only glucose-lowering drug will be enrolled in the study. The effect of a 14-day metformin treatment course on postprandial glucose tolerance will be examined with and without infusion of the GLP-1 receptor antagonist exendin9-39 in 15 patients with type 2 diabetes.
The double-blinded, placebo-controlled, randomised, cross-over study consists of four study days with concomitant infusions of A) placebo + placebo, B) placebo + exendin9-39, C) metformin + placebo and D) metformin + exendin9-39.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo, oral tablet in 14 days and in liquid meal. |
| Metformin | Experimental | Drug: MetforminMetformin, oral tablet 2-4 x 500 mg in 14 days and in liquid meal. |
| Saline | Experimental | Drug: SalineSaline infusion (9mg/mL) on experimental days |
| Exendin(9-39) | Experimental | Drug: Exendin (9-39)Exendin(9-39) infusion. GLP-1 receptor antagonist used as a study tool on experimental days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Oral Tablet2-4 tablets in 14 days | Drug | Placebo |
| Metformin1000-2000 mg in 14 days | Drug | Metformin |
| Saline9 mg/ml saline infusion during experimental days | Drug | Saline |
| Exendin (9-39)Infusion of GLP-1 receptor antagonist used as a tool during experimental days | Drug | Exendin(9-39) |
Primary outcome
Plasma glucose
Time frame: Minutes 240
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Derived from this study: PubMed 39049802Hansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K Knop, MD, PhD study director
UHGentofte, Center for Diabetes Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin, Saline and Exendin (9-39) in people with Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (time frame: Minutes 240). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.