HealthyPhase 1NCT01021527
A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)
A Phase 1 study testing Comparator: Treatment A, Comparator: Treatment B and Comparator: Treatment C in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial summary
A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Comparator: Treatment A, Comparator: Treatment B and Comparator: Treatment C
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Apr 2008
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in good health
- Subject is a non-smoker
Who cannot join
- Subject has irritable bowel disease
- Subject has a history of cancer
- Subject has a history of hypertension requiring treatment
- Subject is unable to refrain from the use of any prescription or non-prescription medication
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
About this study
Official title: A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose
A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.
- Conditions
- Healthy
- Being tested
- Comparator: Treatment A, Comparator: Treatment B, Comparator: Treatment C, Comparator: graded glucose infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: Treatment AOther
No Treatment
Comparator: Treatment BDrug
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment CDrug
single dose administration of exenatide 10ug by subcutaneous injection
Comparator: graded glucose infusionProcedure or surgery
A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | A-B-C-C Receives: Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion |
| Treatment Sequence 2 | Experimental | B-C-A-C Receives: Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion |
| Treatment Sequence 3 | Experimental | C-A-B-C Receives: Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion |
| Treatment Sequence 4 | Experimental | A-C-B-C Receives: Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion |
| Treatment Sequence 5 | Experimental | B-A-C-C Receives: Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion |
| Treatment Sequence 6 | Experimental | C-B-A-C Receives: Other: Comparator: Treatment A; Drug: Comparator: Treatment B; Drug: Comparator: Treatment C; Procedure: Comparator: graded glucose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
Measured: 0-160 minutes after start of infusion
Secondary outcomes (1)
safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021527
- Sponsor's protocol ID
- 0000-099
- Other IDs
- 099, 2009_697
- Status last verified
- Apr 2015
- First submitted
- 25 Nov 2009
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose
- ClinicalTrials.gov ID
- NCT01021527
- Acronym / sponsor ID
- 0000-099
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 30 Nov 2009 (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.
A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Other: Comparator: Treatment A, Drug: Comparator: Treatment B, Drug: Comparator: Treatment C, Procedure: Comparator: graded glucose infusionA-B-C-C |
| Treatment Sequence 2 | Experimental | Other: Comparator: Treatment A, Drug: Comparator: Treatment B, Drug: Comparator: Treatment C, Procedure: Comparator: graded glucose infusionB-C-A-C |
| Treatment Sequence 3 | Experimental | Other: Comparator: Treatment A, Drug: Comparator: Treatment B, Drug: Comparator: Treatment C, Procedure: Comparator: graded glucose infusionC-A-B-C |
| Treatment Sequence 4 | Experimental | Other: Comparator: Treatment A, Drug: Comparator: Treatment B, Drug: Comparator: Treatment C, Procedure: Comparator: graded glucose infusionA-C-B-C |
| Treatment Sequence 5 | Experimental | Other: Comparator: Treatment A, Drug: Comparator: Treatment B, Drug: Comparator: Treatment C, Procedure: Comparator: graded glucose infusionB-A-C-C |
| Treatment Sequence 6 | Experimental | Other: Comparator: Treatment A, Drug: Comparator: Treatment B, Drug: Comparator: Treatment C, Procedure: Comparator: graded glucose infusionC-B-A-C |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject is in good health
- Subject is a non-smoker
Key exclusion criteria (6 listed)
- Subject has irritable bowel disease
- Subject has a history of cancer
- Subject has a history of hypertension requiring treatment
- Subject is unable to refrain from the use of any prescription or non-prescription medication
- Subject consumes excessive amounts of alcohol or caffeine
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 |
|---|---|---|
| Comparator: Treatment ANo Treatment | Other | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6 |
| Comparator: Treatment Bsingle dose administration of exenatide 5ug by subcutaneous injection | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6 |
| Comparator: Treatment Csingle dose administration of exenatide 10ug by subcutaneous injection | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6 |
| Comparator: graded glucose infusionA stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods. | Procedure or surgery | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6 |
Primary outcome
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
Time frame: 0-160 minutes after start of infusion
1 secondary outcome
safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences
Time frame: 11 weeks
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 28 Apr 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: Treatment A, Comparator: Treatment B and Comparator: Treatment C in people with Healthy, run by Merck Sharp & Dohme LLC.
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 6 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) (time frame: 0-160 minutes after start of infusion). 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 Apr 2015.