Type 2 Diabetes MellitusPhase 2NCT00824616

A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

A Phase 2 study testing MK-0941 and Insulin 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.

Trial summary

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes. Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MK-0941 and Insulin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: No sites listed yet
Study dates: Jan 2009to May 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 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has Type 2 Diabetes Mellitus

Who cannot join

Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
Participant has had surgery within 30 days of starting the study or has planned major surgery

About this study

Official title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Conditions: Type 2 Diabetes Mellitus
Being tested: MK-0941, Placebo, 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
MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.
PlaceboDrug
Placebo tablets, taken 3 times daily.
InsulinDrug
Also called LANTUS®
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Study groups in NCT00824616
Study group	Role	What they receive
Placebo	Placebo comparator	Participants receiving placebo tablets three times daily plus insulin injection once daily Receives: Drug: Placebo; Drug: Insulin
MK-0941	Experimental	Participants receiving MK-0941 tablets three times daily plus insulin injection once daily Receives: Drug: MK-0941; Drug: Insulin

What is being measured

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

Change From Baseline in Hemoglobin A1c (HbA1c) Level
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Measured: Baseline (Day 1) and End of Treatment (Week 20)
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.
Measured: From first dose of study drug (Week 0) to last dose of study drug (Week 20)

Timeline

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

Jan 2009May 2010

First posted19 Jan 2009 (estimated)
Study startJan 2009
Primary completionMay 2010
Study completionMay 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00824616
Sponsor's protocol ID: 0941-018
Other IDs: 2009_516, MK-0941-018
Status last verified: Jul 2015
First submitted: 16 Jan 2009
Last updated: 28 Jul 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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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
ClinicalTrials.gov ID: NCT00824616
Acronym / sponsor ID: 0941-018
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 19 Jan 2009 (estimated)
Results: Posted 21 Aug 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 MK-0941 as add-on therapy for adults taking insulin 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
Placebo	Placebo comparator	Drug: Placebo, Drug: InsulinParticipants receiving placebo tablets three times daily plus insulin injection once daily
MK-0941	Experimental	Drug: MK-0941, Drug: InsulinParticipants receiving MK-0941 tablets three times daily plus insulin injection once daily

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participant has Type 2 Diabetes Mellitus

Key exclusion criteria (3 listed)

Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
Participant has had surgery within 30 days of starting the study or has planned major surgery

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 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.	Drug	MK-0941
PlaceboPlacebo tablets, taken 3 times daily.	Drug	Placebo
InsulinAlso: LANTUS®Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.	Drug	MK-0941, Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) Level
Time frame: Baseline (Day 1) and End of Treatment (Week 20)
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Time frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20)
Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.

Results and safety

Results posted to the registry on 21 Aug 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
Placebo	34	28
MK-0941	34	27

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) Level

Time frame: Baseline (Day 1) and End of Treatment (Week 20). Least squares mean (95% Confidence Interval). Unit: % HbA1c

Measure	Placebo n = 34	MK-0941 n = 34
Value	-0.15 (-0.65 to 0.34)	-0.26 (-0.76 to 0.23)

Placebo vs MK-0941: Mean Difference (Net): -0.11 (95% CI -0.81 to 0.58), p = 0.745, Longitudinal Data Analysis (LDA) model

Population analysed: Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.

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

Time frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20). Number. Unit: participants

Measure	Placebo n = 34	MK-0941 n = 34
Value	6	8

Placebo vs MK-0941: Proportions: 5.9 (95% CI -13.7 to 25.4), p = 0.537, Miettinen & Nurminen method

Population analysed: All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).

Adverse events

Time frame: From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 34 (2.9%)	13 of 34 (38.2%)	Not reported
MK-0941	1 of 34 (2.9%)	11 of 34 (32.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction

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 and 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 1 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 28 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 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 21 Aug 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 in Hemoglobin A1c (HbA1c) Level (time frame: Baseline (Day 1) and End of Treatment (Week 20)). 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 NCT00824616.

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 Jul 2015.