Type 2 Diabetes MellitusPhase 1NCT00511472
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
A Phase 1 study testing MK-0941 and LANTUS insulin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MK-0941 and LANTUS insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Apr 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (of non-childbearing potential) between 18 to 70 years of age
- Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
- Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules
Who cannot join
- History of Type 1 diabetes
- Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
- History of severe hypoglycemia
- Allergic to insulin
About this study
Official title: A Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 on Postprandial Plasma Glucose Concentrations After Daily Administration MK-0941 Before Each Meal (q.a.c) in Subjects With Type 2 Diabetes Being Treated With Basal Insulin
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MK-0941, Placebo, LANTUS insulin
- 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.
MK-0941Drug
In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.
Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2.
PlaceboDrug
10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
LANTUS insulinDrug
Also called LANTUS
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
| Study group | Role | What they receive |
|---|---|---|
| MK-0941 | Experimental | Not described Receives: Drug: MK-0941; Drug: LANTUS insulin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: LANTUS insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event During the Study
Measured: 39 days
Secondary outcomes (4)
Number of Participants Who Experienced an Adverse Event - Titration Scheme 1
In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study.
Measured: 25 days
Number of Participants Who Experienced an Adverse Event - Titration Scheme 2
Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.
Measured: 25 days
24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7
Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.
Measured: 24 hours
Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period
During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.
Measured: Outpatient Days 1 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
- NCT00511472
- Sponsor's protocol ID
- 0941-006
- Other IDs
- 2007_596, MK-0941-006
- Status last verified
- Jun 2015
- First submitted
- 2 Aug 2007
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 on Postprandial Plasma Glucose Concentrations After Daily Administration MK-0941 Before Each Meal (q.a.c) in Subjects With Type 2 Diabetes Being Treated With Basal Insulin
- ClinicalTrials.gov ID
- NCT00511472
- Acronym / sponsor ID
- 0941-006
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Posted 11 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-0941 | Experimental | Drug: MK-0941, Drug: LANTUS insulin |
| Placebo | Placebo comparator | Drug: Placebo, Drug: LANTUS insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female (of non-childbearing potential) between 18 to 70 years of age
- Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
- Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules
Key exclusion criteria (4 listed)
- History of Type 1 diabetes
- Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
- History of severe hypoglycemia
- Allergic to insulin
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 |
|---|---|---|
| MK-0941In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments. Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2. | Drug | MK-0941 |
| Placebo10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c. | Drug | Placebo |
| LANTUS insulinAlso: LANTUSLANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin | Drug | MK-0941, Placebo |
Primary outcome
Number of Participants Who Experienced an Adverse Event During the Study
Time frame: 39 days
4 secondary outcomes
Number of Participants Who Experienced an Adverse Event - Titration Scheme 1
Time frame: 25 days
Number of Participants Who Experienced an Adverse Event - Titration Scheme 2
Time frame: 25 days
24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7
Time frame: 24 hours
Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period
Time frame: Outpatient Days 1 to 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- 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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-0941 and LANTUS insulin 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 3 inclusion and 4 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 15 Jul 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. Some participants in this study may receive a placebo. 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 11 Jul 2012). 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?
Number of Participants Who Experienced an Adverse Event During the Study (time frame: 39 days). 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 15 Jul 2015.