Diabetes Mellitus, Type 2Phase 2NCT00767000

Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to… Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: MK-0941, Lantus and Metformin
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: 813 participants
Where: No sites listed yet
Study dates: Oct 2008to Jun 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

has type 2 diabetes mellitus
has body mass index >20 and <43 kg/m^2
is a male, or a female who is unlikely to conceive
currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus
Extension Study Inclusion Criteria:
completed the base study either on double-blind study medication or as part of the post-treatment follow up population
had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period

Who cannot join

has any history of Type 1 diabetes mellitus or ketoacidosis
has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
has undergone surgery within 30 days prior to Visit 1 or has planned major surgery

About this study

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

Read the detailed description

This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

Conditions: Diabetes Mellitus, Type 2
Being tested: MK-0941, Comparator: Placebo, Lantus, 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 tablets three times daily
Comparator: PlaceboDrug
Matching placebo to MK-0941 three times daily
LantusBiological
Also called Insulin glargine injection
Lantus injection once daily
MetforminDrug
Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

Study groups in NCT00767000
Study group	Role	What they receive
MK-0941 10 mg	Experimental	Not described Receives: Drug: MK-0941; Biological: Lantus; Drug: Metformin
MK-0941 20 mg	Experimental	Not described Receives: Drug: MK-0941; Biological: Lantus; Drug: Metformin
MK-0941 30 mg	Experimental	Not described Receives: Drug: MK-0941; Biological: Lantus; Drug: Metformin
MK-0941 40 mg	Experimental	Not described Receives: Drug: MK-0941; Biological: Lantus; Drug: Metformin
Placebo	Placebo comparator	Not described Receives: Drug: Comparator: Placebo; Biological: Lantus; Drug: Metformin

What is being measured

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

Change in Hemoglobin A1c (HbA1c) Level
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Measured: Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Experienced at Least One Adverse Event
Measured: Entire study including 54-week study and 104-week extension
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Measured: Entire study including 54-week study and 104-week extension

Secondary outcomes (4)

Change in the Two-hour Post Meal Glucose Level
Least squares mean change from baseline in 2-hour post meal glucose level.
Measured: Baseline and Weeks 14, 54, 106, and 158
Change in the Fasting Plasma Glucose Level
Least squares mean change from baseline in fasting plasma glucose.
Measured: Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Achieve an HbA1c of <7.0%
Measured: Weeks 106 and 158
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Measured: Weeks 54, 106 and 158

Timeline

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

Oct 2008Jun 2010

First posted6 Oct 2008 (estimated)
Study startOct 2008
Primary completionApr 2010
Study completionJun 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies 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: 813 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00767000
Sponsor's protocol ID: 0941-007
Other IDs: 2008_557
Status last verified: Feb 2015
First submitted: 3 Oct 2008
Last updated: 19 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.
PubMed 21994424

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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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
ClinicalTrials.gov ID: NCT00767000
Acronym / sponsor ID: 0941-007
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 813 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Apr 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 6 Oct 2008 (estimated)
Results: Posted 3 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
MK-0941 10 mg	Experimental	Drug: MK-0941, Biological: Lantus, Drug: Metformin
MK-0941 20 mg	Experimental	Drug: MK-0941, Biological: Lantus, Drug: Metformin
MK-0941 30 mg	Experimental	Drug: MK-0941, Biological: Lantus, Drug: Metformin
MK-0941 40 mg	Experimental	Drug: MK-0941, Biological: Lantus, Drug: Metformin
Placebo	Placebo comparator	Drug: Comparator: Placebo, Biological: Lantus, Drug: Metformin

Who may qualify

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

Key inclusion criteria (7 listed)

has type 2 diabetes mellitus
has body mass index >20 and <43 kg/m^2
is a male, or a female who is unlikely to conceive
currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus
completed the base study either on double-blind study medication or as part of the post-treatment follow up population

Key exclusion criteria (5 listed)

has any history of Type 1 diabetes mellitus or ketoacidosis
has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
has undergone surgery within 30 days prior to Visit 1 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 three times daily	Drug	MK-0941 10 mg, MK-0941 20 mg, MK-0941 30 mg, MK-0941 40 mg
Comparator: PlaceboMatching placebo to MK-0941 three times daily	Drug	Placebo
LantusAlso: Insulin glargine injectionLantus injection once daily	Biological	MK-0941 10 mg, MK-0941 20 mg, MK-0941 30 mg, MK-0941 40 mg, Placebo
MetforminMetformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.	Drug	MK-0941 10 mg, MK-0941 20 mg, MK-0941 30 mg, MK-0941 40 mg, Placebo

Primary outcome

Change in Hemoglobin A1c (HbA1c) Level
Time frame: Baseline and Weeks 14, 54, 106, and 158
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Percentage of Participants Who Experienced at Least One Adverse Event
Time frame: Entire study including 54-week study and 104-week extension
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Time frame: Entire study including 54-week study and 104-week extension

4 secondary outcomes

Change in the Two-hour Post Meal Glucose Level
Time frame: Baseline and Weeks 14, 54, 106, and 158
Change in the Fasting Plasma Glucose Level
Time frame: Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Achieve an HbA1c of <7.0%
Time frame: Weeks 106 and 158
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Time frame: Weeks 54, 106 and 158

Results and safety

Results posted to the registry on 3 Sep 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 10 mg	119	11
MK-0941 20 mg	117	4
MK-0941 30 mg	117	8
MK-0941 40 mg	229	4
Placebo	231	7

Primary outcome: Change in Hemoglobin A1c (HbA1c) Level

Time frame: Baseline and Weeks 14, 54, 106, and 158. Least squares mean (95% Confidence Interval). Unit: Percent HbA1c

Measure	MK-0941 10 mg n = 118	MK-0941 20 mg n = 117	MK-0941 30 mg n = 117	MK-0941 40 mg n = 118	Placebo n = 115
Week 14	-0.59 (-0.80 to -0.38)	-0.72 (-0.92 to -0.52)	-0.89 (-1.10 to -0.69)	-0.83 (-1.03 to -0.62)	-0.08 (-0.28 to 0.13)
Week 54 (no participants analyzed)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)
Week 106 (no participants analyzed)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)
Week 158 (no participants analyzed)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

MK-0941 10 mg vs Placebo: Least Squares Mean Difference: -0.51 (95% CI -0.80 to -0.22), p <0.001, Constrained longitudinal model
MK-0941 20 mg vs Placebo: Least Squares Mean Difference: -0.64 (95% CI -0.93 to -0.36), p <0.001, Constrained longitudinal model
MK-0941 30 mg vs Placebo: Least Squares Mean Difference: -0.81 (95% CI -1.10 to -0.53), p <0.001, Contrained longitudinal model

Population analysed: Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event

Time frame: Entire study including 54-week study and 104-week extension. Number. Unit: percentage of participants

Measure	MK-0941 10 mg n = 119	MK-0941 20 mg n = 117	MK-0941 30 mg n = 117	MK-0941 40 mg n = 229	Placebo n = 231
Value	80.7	79.5	80.3	65.5	65.4

Population analysed: Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.

Primary outcome: Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event

Time frame: Entire study including 54-week study and 104-week extension. Number. Unit: percentage of participants

Measure	MK-0941 10 mg n = 119	MK-0941 20 mg n = 117	MK-0941 30 mg n = 117	MK-0941 40 mg n = 229	Placebo n = 231
Value	3.4	5.1	6.8	3.1	1.7

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the entire study including the 54-week study and 104-week extension. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0941 10 mg	11 of 119 (9.2%)	74 of 119 (62.2%)	Not reported
MK-0941 20 mg	12 of 117 (10.3%)	75 of 117 (64.1%)	Not reported
MK-0941 30 mg	11 of 117 (9.4%)	78 of 117 (66.7%)	Not reported
MK-0941 40 mg	13 of 229 (5.7%)	120 of 229 (52.4%)	Not reported
Placebo	8 of 231 (3.5%)	101 of 231 (43.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21994424Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.

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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, Lantus and Metformin in people with Diabetes Mellitus, Type 2, 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 7 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: stopped early, as of the sponsor's last update on 19 Feb 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 3 Sep 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 in Hemoglobin A1c (HbA1c) Level (time frame: Baseline and Weeks 14, 54, 106, and 158). The study lists 3 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 NCT00767000, 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 19 Feb 2015.