MK-3102 Phase III Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015 AM1)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01697592
First received: September 28, 2012
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
This study will examine the safety and efficacy of the addition of MK-3102 in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: MK-3102 Drug: Matching placebo to MK-3102 Drug: Basal medication |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes
Diabetes Medicines
Diabetes Type 2
Exercise and Physical Fitness
Drug Information available for:
Metformin
Metformin hydrochloride
Glyburide
Acarbose
Miglitol
Glimepiride
Nateglinide
Pioglitazone
Pioglitazone hydrochloride
Repaglinide
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Percentage of participants who experienced at least one adverse event [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
- Percentage of participants who experienced at least one adverse event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
- Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
- Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 568 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MK-3102
MK-3102 25 mg administered orally once weekly for 52 weeks (24 weeks during Period A and 28 weeks during Period B). Participants continued pre-study basal medication throughout the duration of the study.
|
Drug: MK-3102
MK-3102 25 mg capsule administered orally once weekly
Drug: Basal medication
Participants continue basal medication at their pre-study dosage (dosage may be up-titrated during the study only if needed for rescue therapy). Basal medication includes any of the following: sulfonylureas (gliclazide, glibenclamide or glimepiride), glinides (nateglinide, mitiglinide or repaglinide), biguanides (metformin), thiazolidinediones (TZDs) (pioglitazone), alpha-glucosidase inhibitors (acarbose, voglibose or miglitol).
Other Names:
|
|
Placebo Comparator: Placebo
Matching placebo to MK-3102 administered orally once weekly for 24 weeks (Period A) followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Period B). Participants continued pre-study basal medication throughout the duration of the study.
|
Drug: MK-3102
MK-3102 25 mg capsule administered orally once weekly
Drug: Matching placebo to MK-3102
Matching placebo to MK-3102 25 mg capsule administered orally once weekly
Drug: Basal medication
Participants continue basal medication at their pre-study dosage (dosage may be up-titrated during the study only if needed for rescue therapy). Basal medication includes any of the following: sulfonylureas (gliclazide, glibenclamide or glimepiride), glinides (nateglinide, mitiglinide or repaglinide), biguanides (metformin), thiazolidinediones (TZDs) (pioglitazone), alpha-glucosidase inhibitors (acarbose, voglibose or miglitol).
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has type 2 diabetes mellitus
- Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy
Exclusion Criteria:
- History of type 1 diabetes mellitus or a history of ketoacidosis
- History of any of the following medications: TZD (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, MK-3102 anytime
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01697592 History of Changes |
| Other Study ID Numbers: | 3102-015 |
| Study First Received: | September 28, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Miglitol Nateglinide Pioglitazone Repaglinide Mitiglinide Voglibose Glyburide |
Gliclazide Hypoglycemic Agents Metformin Acarbose Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013