Type 2 DiabetesPhase 1/2NCT00609154
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
A Phase 1/2 study testing glucagon like peptide-1 in people with Type 2 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- glucagon like peptide-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2010to 13 May 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes
- Non diabetic
Who cannot join
- Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
- Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
- Anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicinie
The Bronx, New York, 10461
About this study
The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.
Read the detailed description
We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- glucagon like peptide-1, glucose control
- Keywords
- Type 2 diabetes, Insulin, biosynthesis, Non diabetic control
- 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.
glucagon like peptide-1Drug
Also called incretin
GLP-1 1 pmole/kg/min
glucose controlDietary supplement
glucose without GLP-1
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Group | Experimental | Participants with Type 2 diabetes Receives: Drug: glucagon like peptide-1; Dietary Supplement: glucose control |
| Non-diabetic Group | Active comparator | Participants who are non-diabetic will serve as control. treatment is matched to experimental group Receives: Drug: glucagon like peptide-1; Dietary Supplement: glucose control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Biosynthesis Rate
Blood insulin biosynthesis rate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study start12 Aug 2010
- Primary completion13 May 2014
- Study completion13 May 2014
Why it stopped: Per source documents the study was terminated well in advance of targeted enrollment. A method for the analysis of insulin and proinsulin samples was never fully developed and validated. Study terminated upon expiration of IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Daniel T Stein, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609154
- Sponsor's protocol ID
- 1999-041, Sub-study #4
- Other IDs
- Sub-study 4, R01DK061644-09
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2008
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates
- ClinicalTrials.gov ID
- NCT00609154
- Acronym / sponsor ID
- 1999-041, Sub-study #4
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Insulin, biosynthesis, Non diabetic control
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per source documents the study was terminated well in advance of targeted enrollment. A method for the analysis of insulin and proinsulin samples was never fully developed and validated. Study terminated upon expiration of IRB approval
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Aug 2010 (actual)
- Primary completion
- 13 May 2014 (actual)
- Study completion
- 13 May 2014 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.
Detailed description
We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Group | Experimental | Drug: glucagon like peptide-1, Dietary Supplement: glucose controlParticipants with Type 2 diabetes |
| Non-diabetic Group | Active comparator | Drug: glucagon like peptide-1, Dietary Supplement: glucose controlParticipants who are non-diabetic will serve as control. treatment is matched to experimental group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes
- Non diabetic
Key exclusion criteria (3 listed)
- Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
- Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
- Anemia
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 |
|---|---|---|
| glucagon like peptide-1Also: incretinGLP-1 1 pmole/kg/min | Drug | Diabetic Group, Non-diabetic Group |
| glucose controlglucose without GLP-1 | Dietary supplement | Diabetic Group, Non-diabetic Group |
Primary outcome
Insulin Biosynthesis Rate
Time frame: 24 hours
Blood insulin biosynthesis rate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel T Stein, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing glucagon like peptide-1 in people with Type 2 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Feb 2024. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Biosynthesis Rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.