Type 2 Diabetes MellitusPhase 1NCT00888238
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
A Phase 1 study testing sitagliptin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure. 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
- Type 2 Diabetes Mellitus
- What is being tested?
- sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2009to 21 Jul 2009
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is an Asian Indian male between 18 to 45 years of age
- Subject is in good health
- Subject is a nonsmoker or has not used nicotine-containing products for six months
- Subject is willing to avoid strenuous activity
Who cannot join
- Subject has a history of stroke, seizures, or major neurological disorders
- Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
- Subject has a history of high blood pressure requiring treatment
- Subject has history of cancer
- Subject has a history of diabetes
About this study
Official title: A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- sitagliptin, Comparator: Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptinDrug
Also called sitagliptin phosphate, MK0431
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
Comparator: PlaceboDrug
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin/Sitagliptin/Placebo | Experimental | Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods Receives: Drug: sitagliptin; Drug: Comparator: Placebo |
| Sitagliptin/Placebo/Sitaglipitin | Experimental | Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods Receives: Drug: sitagliptin; Drug: Comparator: Placebo |
| Placebo/Sitagliptin/Sitagliptin | Experimental | Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods Receives: Drug: sitagliptin; Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
Measured: 190 minutes to 340 minutes
Secondary outcomes (1)
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).
Measured: 190 minutes to 340 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study start12 May 2009
- Primary completion10 Jun 2009
- Study completion21 Jul 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT00888238
- Sponsor's protocol ID
- 0431-179
- Other IDs
- 2009_584, CTRI/2009/091/000457
- Status last verified
- Mar 2018
- First submitted
- 24 Apr 2009
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shankar SS, Shankar RR, Mixson LA, Miller DL, Steinberg HO, Beals CR, Kelley DE. Insulin secretory effect of sitagliptin: assessment with a hyperglycemic clamp combined with a meal challenge. Am J Physiol Endocrinol Metab. 2018 Apr 1;314(4):E406-E412. doi: 10.1152/ajpendo.00238.2017. Epub 2017 Nov 14.
PubMed 29138226
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
- ClinicalTrials.gov ID
- NCT00888238
- Acronym / sponsor ID
- 0431-179
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 May 2009 (actual)
- Primary completion
- 10 Jun 2009 (actual)
- Study completion
- 21 Jul 2009 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Posted 3 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin/Sitagliptin/Placebo | Experimental | Drug: sitagliptin, Drug: Comparator: PlaceboSitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods |
| Sitagliptin/Placebo/Sitaglipitin | Experimental | Drug: sitagliptin, Drug: Comparator: PlaceboSitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods |
| Placebo/Sitagliptin/Sitagliptin | Experimental | Drug: sitagliptin, Drug: Comparator: PlaceboSitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is an Asian Indian male between 18 to 45 years of age
- Subject is in good health
- Subject is a nonsmoker or has not used nicotine-containing products for six months
- Subject is willing to avoid strenuous activity
Key exclusion criteria (5 listed)
- Subject has a history of stroke, seizures, or major neurological disorders
- Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
- Subject has a history of high blood pressure requiring treatment
- Subject has history of cancer
- Subject has a history of diabetes
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 |
|---|---|---|
| sitagliptinAlso: sitagliptin phosphate, MK0431Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test. | Drug | Placebo/Sitagliptin/Sitagliptin, Sitagliptin/Placebo/Sitaglipitin, Sitagliptin/Sitagliptin/Placebo |
| Comparator: PlaceboSingle oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test. | Drug | Placebo/Sitagliptin/Sitagliptin, Sitagliptin/Placebo/Sitaglipitin, Sitagliptin/Sitagliptin/Placebo |
Primary outcome
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
Time frame: 190 minutes to 340 minutes
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
1 secondary outcome
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
Time frame: 190 minutes to 340 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29138226Shankar SS, Shankar RR, Mixson LA, Miller DL, Steinberg HO, Beals CR, Kelley DE. Insulin secretory effect of sitagliptin: assessment with a hyperglycemic clamp combined with a meal challenge. Am J Physiol Endocrinol Metab. 2018 Apr 1;314(4):E406-E412. doi: 10.1152/ajpendo.00238.2017. Epub 2017 Nov 14.
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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 sitagliptin in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 5 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 26 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2010). 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 Secretion Rate (ISR) During 190 - 340 Minutes Post-dose (time frame: 190 minutes to 340 minutes). 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 NCT00888238, 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 26 Jun 2018.