Type 2 Diabetes MellitusPhase 2NCT00792935

A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)

A Phase 2 study testing MK-0941, Glimepiride and Metformin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes. 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, Glimepiride and Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: No sites listed yet
Study dates: Jan 2009to Feb 2010
Phase: Phase 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has type 2 diabetes mellitus
Between the ages of 18 and 70

Who cannot join

Patient has a history of type 1 diabetes mellitus or ketoacidosis.
Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
Patient has had surgery within 30 days of starting the study or has planned major surgery during the study

About this study

Official title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.

Conditions: Type 2 Diabetes Mellitus
Being tested: MK-0941, Glimepiride, Metformin
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
MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.
GlimepirideDrug
Also called Amaryl®
Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.
MetforminDrug
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.

Study groups in NCT00792935
Study group	Role	What they receive
MK-0941	Experimental	Not described Receives: Drug: MK-0941; Drug: Metformin
Glimepiride	Active comparator	Not described Receives: Drug: Glimepiride; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Measured: Baseline and Week 6
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Hypoglycemic episodes are defined as either a fingerstick glucose
measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia.
Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Feb 2010

First posted18 Nov 2008 (estimated)
Study startJan 2009
Primary completionFeb 2010
Study completionFeb 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00792935
Sponsor's protocol ID: 0941-017
Other IDs: 2008_589, CTRI/2009/091/000154
Status last verified: Dec 2015
First submitted: 14 Nov 2008
Last updated: 17 Dec 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy
ClinicalTrials.gov ID: NCT00792935
Acronym / sponsor ID: 0941-017
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 18 Nov 2008 (estimated)
Results: Posted 3 Oct 2012

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 this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.

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: Metformin
Glimepiride	Active comparator	Drug: Glimepiride, Drug: Metformin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient has type 2 diabetes mellitus
Between the ages of 18 and 70

Key exclusion criteria (3 listed)

Patient has a history of type 1 diabetes mellitus or ketoacidosis.
Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
Patient has had surgery within 30 days of starting the study or has planned major surgery during the study

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-0941MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.	Drug	MK-0941
GlimepirideAlso: Amaryl®Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.	Drug	Glimepiride
MetforminThe study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.	Drug	Glimepiride, MK-0941

Primary outcome

Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
Time frame: Baseline and Week 6
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Time frame: Baseline to Week 6
Hypoglycemic episodes are defined as either a fingerstick glucose measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia.

Results and safety

Results posted to the registry on 3 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-0941	72	68
Glimepiride	71	68

Primary outcome: Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose

Time frame: Baseline and Week 6. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	MK-0941 n = 72	Glimepiride n = 71
Value	-43.4 (-50.0 to -36.8)	-44.2 (-50.9 to -37.5)

MK-0941 vs Glimepiride: Mean Difference (Final Values): 0.9 (95% CI -7.9 to 9.6), p = 0.847, Constrained longitudinal analysis

Population analysed: The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).

Primary outcome: Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)

Time frame: Baseline to Week 6. Number. Unit: participants

Measure	MK-0941 n = 72	Glimepiride n = 71
Value	32	37

MK-0941 vs Glimepiride: Proportions: -7.7 (95% CI -23.6 to 8.7), p = 0.361, Miettinen & Nurminen method.

Population analysed: All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.

Adverse events

Time frame: 14 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0941	1 of 72 (1.4%)	31 of 72 (43.1%)	Not reported
Glimepiride	1 of 71 (1.4%)	25 of 71 (35.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Not yet recruiting
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Active, not recruitingPhase 1/2
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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 2 study testing MK-0941, Glimepiride and Metformin 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 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: finished, as of the sponsor's last update on 17 Dec 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 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 3 Oct 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?

Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose (time frame: Baseline and Week 6). The study lists 2 primary outcomes in all. 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 NCT00792935.

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 17 Dec 2015.