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

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ClinicalTrials.gov Identifier: NCT00767000
Recruitment Status : Terminated
First Posted : October 6, 2008
Results First Posted : September 3, 2012
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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 insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: MK-0941 Drug: Comparator: Placebo Biological: Lantus Drug: Metformin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MK-0941 10 mg Drug: MK-0941
MK-0941 tablets three times daily

Biological: Lantus
Lantus injection once daily
Other Name: Insulin glargine injection

Drug: Metformin
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.

Experimental: MK-0941 20 mg Drug: MK-0941
MK-0941 tablets three times daily

Biological: Lantus
Lantus injection once daily
Other Name: Insulin glargine injection

Drug: Metformin
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.

Experimental: MK-0941 30 mg Drug: MK-0941
MK-0941 tablets three times daily

Biological: Lantus
Lantus injection once daily
Other Name: Insulin glargine injection

Drug: Metformin
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.

Experimental: MK-0941 40 mg Drug: MK-0941
MK-0941 tablets three times daily

Biological: Lantus
Lantus injection once daily
Other Name: Insulin glargine injection

Drug: Metformin
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.

Placebo Comparator: Placebo Drug: Comparator: Placebo
Matching placebo to MK-0941 three times daily

Biological: Lantus
Lantus injection once daily
Other Name: Insulin glargine injection

Drug: Metformin
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.




Primary Outcome Measures :
  1. 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.

  2. Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Entire study including 54-week study and 104-week extension ]
  3. Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event [ Time Frame: Entire study including 54-week study and 104-week extension ]

Secondary Outcome Measures :
  1. Change in the Two-hour Post Meal Glucose Level [ Time Frame: Baseline and Weeks 14, 54, 106, and 158 ]
    Least squares mean change from baseline in 2-hour post meal glucose level.

  2. Change in the Fasting Plasma Glucose Level [ Time Frame: Baseline and Weeks 14, 54, 106, and 158 ]
    Least squares mean change from baseline in fasting plasma glucose.

  3. Percentage of Participants Who Achieve an HbA1c of <7.0% [ Time Frame: Weeks 106 and 158 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767000


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00767000     History of Changes
Other Study ID Numbers: 0941-007
2008_557
First Posted: October 6, 2008    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: February 19, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs