Type 2 DiabetesNCT01507597
The Effect of GLP-1 on the Inhibition of Glucagon Secretion
A study testing Native human Glucagon-like Peptide-1 ( GLP-1(7-36)) and NaCl in people with Type 2 Diabetes and Type 1 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Diabetes(both types) are recognized by high levels of glucagon in the circulation. Glucagon is known to increase blood glucose, and might therefore contribute to the respective diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon secretion. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Type 1 Diabetes
- What is being tested?
- Native human Glucagon-like Peptide-1 ( GLP-1(7-36)) and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Aug 2013
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with T2DM
- Above the age of 35 years, treatment with diet or oral anti-diabetic medication. Diagnosed with T2DM in at leat three months in advance(WHO criterion)
- Normal hemoglobin
- Informed content Patients with T1DM
- T1DM (WHO criterion)
- Plasma-C-peptid negative due to arginin-test
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- Normal hemoglobin
- age> 18 years
- Informed content Healthy subjects
- Normal fasting plasma glucose and normal glucose tolerance (WHO criterion)
- Normal hemoglobin
- Age >18 years
- Informed content
Who cannot join
- Patients with T2DM
- Treatment with glitazones and/or gliptins
- Inflammatory bowels disease
- previous bowel resection with or without stomy
- Nephropathy (serum creatinin >150 µM and/or albuminuria)
- Liver disease (serum alanine-aminotransferase (ALAT) and/or serum aspartate-aminotransferase (ASAT) >2×normal values)
Show all 26Show fewer
- Medical treatment impossible to break for 12h.
- Age >80 years Patients with T1DM
- Overweight (BMI >30 kg/m2)
- Inflammatory bowels disease
- previous bowel resection with or without stomy
- Nephropathy (serum creatinin >150 µM and/or albuminuria)
- Liver disease (serum alanine-aminotransferase (ALAT) and/or serum aspartate-aminotransferase (ASAT) >2×normal values)
- Medical treatment impossible to break for 12h (except treatment with insulin).
- Age >80 years
- Healthy subjects
- Diabetes
- Prediabetes (impaired glucose tolerance and/or impaired fasting plasma glucose)
- First order relatives with diabetes
- Overweight (BMI >30 kg/m2)
- Inflammatory bowels disease
- previous bowel resection with or without stomy
- Nephropathy (serum creatinin >150 µM and/or albuminuria)
- Liver disease (serum alanine-aminotransferase (ALAT) and/or serum aspartate-aminotransferase (ASAT) >2×normal values)
- Medical treatment impossible to break for 12h.
- Age >80 years
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes(both types) are recognized by high levels of glucagon in the circulation.
Glucagon is known to increase blood glucose, and might therefore contribute to the respective diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon secretion.
The investigators aim to identify the impact of GLP-1 on the glucagon secretion, at increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and in patients with type 1 diabetes.
The investigators think that the effect of GLP-1 on the glucagon secretion might be dependent of blood glucose levels.
- Conditions
- Type 2 Diabetes, Type 1 Diabetes
- Being tested
- Native human Glucagon-like Peptide-1 ( GLP-1(7-36)), NaCl
- Keywords
- Glucagon-like peptide-1, Glucagon, Normal physiology, T2DM, T1DM
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native human Glucagon-like Peptide-1 ( GLP-1(7-36))Drug
Continuous iv. infusion of the native gut hormone GLP-1 (0.2 pmol/kg/min) for 210 minutes.
Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)
NaClDrug
Continuous iv. saline infusion (NaCl Isotonic) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)
Native human Glucagon-like Peptide-1 ( GLP-1(7-36))Drug
Continuous iv. infusion of the native gut hormone GLP-1 (0.4 pmol/kg/min) for 210 minutes.
Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)
Native human Glucagon-like Peptide-1 ( GLP-1(7-36))Drug
Continuous iv. infusion of the native gut hormone GLP-1 (0.8 pmol/kg/min) for 210 minutes.
Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Other | Not described Receives: Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)); Drug: NaCl |
| T2DM | Other | Not described Receives: Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)); Drug: NaCl |
| T1DM | Other | Not described Receives: Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)); Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucagon response to the GLP-1 infusion / glucose clamp
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Measured: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
Plasma GLP-1 response to the GLP-1 infusion / glucose clamp
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Measured: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
Plasma Glucose response to the GLP-1 infusion / glucose clamp
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Measured: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
Secondary outcomes (5)
Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp
Assessed by indirect calorimetry during the GLP-1 infusion / glucose clamp-session
Measured: at 0, 120, and 180 min
Hunger scores response to the GLP-1 infusion / glucose clamp
Assessed by VAS during the 210 min GLP-1 infusion / glucose clamp-session
Measured: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
plasma Insulin response to the GLP-1 infusion / glucose clamp
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Measured: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
plasma GIP response to the GLP-1 infusion / glucose clamp
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Measured: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
Food Intake
Assessed by ad'libitum meal after the 210 min GLP-1 infusion / glucose clamp.
Measured: at 210 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
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 Type 2 DiabetesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507597
- Sponsor's protocol ID
- GlukaStase
- Other IDs
- H-3-2011-088
- Status last verified
- Dec 2013
- First submitted
- 13 Dec 2011
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bagger JI, Grondahl MFG, Lund A, Holst JJ, Vilsboll T, Knop FK. Glucagonostatic Potency of GLP-1 in Patients With Type 2 Diabetes, Patients With Type 1 Diabetes, and Healthy Control Subjects. Diabetes. 2021 Jun;70(6):1347-1356. doi: 10.2337/db20-0998. Epub 2021 Mar 15.
PubMed 33722838
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GLP-1 on the Inhibition of Glucagon Secretion
- ClinicalTrials.gov ID
- NCT01507597
- Acronym / sponsor ID
- GlukaStase
- Conditions
- Type 2 Diabetes, Type 1 Diabetes
- Keywords
- Glucagon-like peptide-1, Glucagon, Normal physiology, T2DM, T1DM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Jan 2012 (estimated)
- 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.
Diabetes(both types) are recognized by high levels of glucagon in the circulation.
Glucagon is known to increase blood glucose, and might therefore contribute to the respective diseases. Under some circumstances the gut hormone GLP-1 inhibits the glucagon secretion.
The investigators aim to identify the impact of GLP-1 on the glucagon secretion, at increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and in patients with type 1 diabetes.
The investigators think that the effect of GLP-1 on the glucagon secretion might be dependent of blood glucose levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Other | Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)), Drug: NaCl |
| T2DM | Other | Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)), Drug: NaCl |
| T1DM | Other | Drug: Native human Glucagon-like Peptide-1 ( GLP-1(7-36)), Drug: NaCl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with T2DM
- Above the age of 35 years, treatment with diet or oral anti-diabetic medication. Diagnosed with T2DM in at leat three months in advance(WHO criterion)
- Normal hemoglobin
- Informed content Patients with T1DM
- T1DM (WHO criterion)
Key exclusion criteria (26 listed)
- Patients with T2DM
- Treatment with glitazones and/or gliptins
- Inflammatory bowels disease
- previous bowel resection with or without stomy
- Nephropathy (serum creatinin >150 µM and/or albuminuria)
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 |
|---|---|---|
| Native human Glucagon-like Peptide-1 ( GLP-1(7-36))Continuous iv. infusion of the native gut hormone GLP-1 (0.2 pmol/kg/min) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step) | Drug | Healthy Subjects, T1DM, T2DM |
| NaClContinuous iv. saline infusion (NaCl Isotonic) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step) | Drug | Healthy Subjects, T1DM, T2DM |
| Native human Glucagon-like Peptide-1 ( GLP-1(7-36))Continuous iv. infusion of the native gut hormone GLP-1 (0.4 pmol/kg/min) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step) | Drug | Healthy Subjects, T1DM, T2DM |
| Native human Glucagon-like Peptide-1 ( GLP-1(7-36))Continuous iv. infusion of the native gut hormone GLP-1 (0.8 pmol/kg/min) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step) | Drug | Healthy Subjects, T1DM, T2DM |
Primary outcome
Plasma Glucagon response to the GLP-1 infusion / glucose clamp
Time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Plasma GLP-1 response to the GLP-1 infusion / glucose clamp
Time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
Plasma Glucose response to the GLP-1 infusion / glucose clamp
Time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
The collection of blood samples will be done during the 210 min GLP-1 infusion / glucose clamp-session
5 secondary outcomes
Resting Metabolic Rate response to the GLP-1 infusion / glucose clamp
Time frame: at 0, 120, and 180 min
Hunger scores response to the GLP-1 infusion / glucose clamp
Time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
plasma Insulin response to the GLP-1 infusion / glucose clamp
Time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
plasma GIP response to the GLP-1 infusion / glucose clamp
Time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min
Food Intake
Time frame: at 210 min
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 10 Dec 2013.
- Derived from this study: PubMed 33722838Bagger JI, Grondahl MFG, Lund A, Holst JJ, Vilsboll T, Knop FK. Glucagonostatic Potency of GLP-1 in Patients With Type 2 Diabetes, Patients With Type 1 Diabetes, and Healthy Control Subjects. Diabetes. 2021 Jun;70(6):1347-1356. doi: 10.2337/db20-0998. Epub 2021 Mar 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native human Glucagon-like Peptide-1 ( GLP-1(7-36)) and NaCl in people with Type 2 Diabetes and Type 1 Diabetes, 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 13 inclusion and 26 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 10 Dec 2013. 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. 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 Glucagon response to the GLP-1 infusion / glucose clamp (time frame: At 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210 min). The study lists 3 primary outcomes in all. 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 NCT01507597, 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 10 Dec 2013.