Diabetes Mellitus, Type 2Phase 1DFG_5NCT01449019
The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing exendin(9-39)amide, saline and duodenal meal in people with Diabetes Mellitus, Type 2, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial summary
The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- exendin(9-39)amide, saline and duodenal meal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2006to Jul 2010
- Phase
- Phase 1
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (T2DM)
- must be able to complete a 1 week wash-out of current anti-diabetic medications
- Age 30-70 years
- HbA1c (Hemoglobin A1c) ≤11% at screening
- Body mass index (BMI) <40 kg/m2
- Patients with type 2 diabetes mellitus (T2DM): Must have a fasting blood glucose of ≤12.2 mmol/L (240 mg/dL) at screening
- Able to provide written informed consent prior to study participation
- Able to communicate well with the investigator and comply with the requirements of the study
Who cannot join
- Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)
- Need for insulin within the previous 3 months
- Use of Thiazolidinediones in the previous 4 weeks
- Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
- Treatment with systemic steroids and thyroid hormone (unstable dosage).
- Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
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- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- Significant illness within the two weeks prior to dosing.
- Past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
- history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- history or clinical evidence of pancreatic injury or pancreatitis;
- history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria);
- evidence of urinary obstruction or difficulty in voiding at screening;
- Polymorphonuclears <1500/µL at inclusion or platelet count < 100,000/μL at screening and baseline.
- History of immunocompromise.
- Evidence of liver disease as indicated by abnormal transaminases and alkaline phosphatase exceeding twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Ludwig Maximilians-University, Clinical Research Unit
Munich, 80999
Clinical Research unit, Dept. of Internal Medicine II - Großhadern, University of Munich
Munich, 81377
About this study
Official title: The Contribution of Glucagon-like Peptide 1 (GLP-1) to the Entero-insulinar Axis in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- exendin(9-39)amide, saline, duodenal meal, duodenal saline
- Keywords
- GLP-1, Exendin(9-39), Insulin, Glucagon, T2DM, incretin effect, human physiology
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exendin(9-39)amideDrug
intravenous infusion of exendin(9-39)
salineDrug
intravenous infusion of saline
duodenal mealOther
duodenal perfusion of a meal
duodenal salineOther
duodenal perfusion of saline
| Study group | Role | What they receive |
|---|---|---|
| intravenous infusion | Active comparator | Not described Receives: Drug: exendin(9-39)amide; Drug: saline |
| intraduodenal perfusion | Experimental | Not described Receives: Other: duodenal meal; Other: duodenal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incretin effect
The incretin effect is the difference between postprandial plasma concentrations of insulin and C-peptide, respectively, and those during the isoglycemic fasting control experiment. The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
Measured: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Secondary outcomes (5)
Plasma concentrations of glucagon
The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
Measured: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of insulin
The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
Measured: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of C-peptide
The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
Measured: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of Glucagon-like peptide-1(7-36) (GLP-1(7-36))
The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
Measured: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of Glucose-dependent insulinotropic polpypeptide (GIP)
The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
Measured: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionJul 2010
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 Diabetes Mellitus, Type 2Studies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Schirra, Ludwig-Maximilians - University of Munich
- Investigators
- Joerg Schirra, MD, Principal investigator, Clinical Research Unit (CRU), Department of Internal Medicine, Campus Großhadern, Clinical Center of Ludwig-Maximilians-University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449019
- Sponsor's protocol ID
- DPI
- Acronym
- DFG_5
- Status last verified
- Oct 2011
- First submitted
- 2 Oct 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woerle HJ, Carneiro L, Derani A, Goke B, Schirra J. The role of endogenous incretin secretion as amplifier of glucose-stimulated insulin secretion in healthy subjects and patients with type 2 diabetes. Diabetes. 2012 Sep;61(9):2349-58. doi: 10.2337/db11-1701. Epub 2012 Jun 20.
PubMed 22721966
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Glucagon-like Peptide 1 (GLP-1) to the Entero-insulinar Axis in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT01449019
- Acronym / sponsor ID
- DFG_5 / DPI
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GLP-1, Exendin(9-39), Insulin, Glucagon, T2DM, incretin effect, human physiology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Oct 2011 (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.
The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous infusion | Active comparator | Drug: exendin(9-39)amide, Drug: saline |
| intraduodenal perfusion | Experimental | Other: duodenal meal, Other: duodenal saline |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (T2DM)
- must be able to complete a 1 week wash-out of current anti-diabetic medications
- Age 30-70 years
- HbA1c (Hemoglobin A1c) ≤11% at screening
- Body mass index (BMI) <40 kg/m2
Key exclusion criteria (18 listed)
- Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)
- Need for insulin within the previous 3 months
- Use of Thiazolidinediones in the previous 4 weeks
- Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
- Treatment with systemic steroids and thyroid hormone (unstable dosage).
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 |
|---|---|---|
| exendin(9-39)amideintravenous infusion of exendin(9-39) | Drug | intravenous infusion |
| salineintravenous infusion of saline | Drug | intravenous infusion |
| duodenal mealduodenal perfusion of a meal | Other | intraduodenal perfusion |
| duodenal salineduodenal perfusion of saline | Other | intraduodenal perfusion |
Primary outcome
The incretin effect
Time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
The incretin effect is the difference between postprandial plasma concentrations of insulin and C-peptide, respectively, and those during the isoglycemic fasting control experiment. The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
5 secondary outcomes
Plasma concentrations of glucagon
Time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of insulin
Time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of C-peptide
Time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of Glucagon-like peptide-1(7-36) (GLP-1(7-36))
Time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Plasma concentrations of Glucose-dependent insulinotropic polpypeptide (GIP)
Time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
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 7 Oct 2011.
- Derived from this study: PubMed 22721966Woerle HJ, Carneiro L, Derani A, Goke B, Schirra J. The role of endogenous incretin secretion as amplifier of glucose-stimulated insulin secretion in healthy subjects and patients with type 2 diabetes. Diabetes. 2012 Sep;61(9):2349-58. doi: 10.2337/db11-1701. Epub 2012 Jun 20.
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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.
Joerg Schirra, MD principal investigator
Clinical Research Unit (CRU), Department of Internal Medicine, Campus Großhadern, Clinical Center of Ludwig-Maximilians-University of Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exendin(9-39)amide, saline and duodenal meal in people with Diabetes Mellitus, Type 2, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
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 8 inclusion and 18 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 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incretin effect (time frame: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion). 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 NCT01449019, 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 7 Oct 2011.