Addition of MK-3102 to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022 AM4)
This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01704261
First received: October 8, 2012
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
This study will examine the safety and efficacy of the addition of MK-3102 in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and sulfonylurea. The primary hypothesis is that after 24 weeks, the addition of treatment with MK-3102 provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: MK-3102 Drug: Matching placebo to MK-3012 Drug: Glimepiride Drug: Metformin |
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, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change from baseline in hemoglobin A1c (A1C) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Percentage of participants attaining A1C glycemic goals of <7% and <6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MK-3102
MK-3102 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
|
Drug: MK-3102
MK-3102 25 mg capsule administered orally once a week
Drug: Glimepiride
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
Other Names:
Drug: Metformin
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
Other Names:
|
|
Placebo Comparator: Placebo
Matching placebo to MK-3102 capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
|
Drug: Matching placebo to MK-3012
Matching placebo to MK-3102 capsule administered orally once a week
Drug: Glimepiride
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
Other Names:
Drug: Metformin
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with type 2 diabetes mellitus
- Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea
- Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug
Exclusion Criteria:
- History of type 1 diabetes mellitus or a history of ketoacidosis
- Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with MK-3102 at any time prior to study participation.
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- On a weight loss program and is not in the maintenance phase; or has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation.
- Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted)
- Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
- Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- Human immunodeficiency virus (HIV)
- New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months
- Poorly controlled hypertension
- History of malignancy <=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Pregnant or breast feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug
- Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 drinks per week, or engages in binge drinking
- Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704261
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| United States, California | |
| Call for Information (Investigational Site 0002) | Recruiting |
| Hillsborough, California, United States, 92868 | |
| Call for Information (Investigational Site 0001) | Recruiting |
| Huntingdon Beach, California, United States, 92647 | |
| United States, Florida | |
| Call for Information (Investigational Site 0008) | Recruiting |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Call for Information (Investigational Site 0003) | Recruiting |
| Orlando, Florida, United States, 32825 | |
| United States, Idaho | |
| Call for Information (Investigational Site 0006) | Recruiting |
| Meridian, Idaho, United States, 83646 | |
| United States, Indiana | |
| Call for Information (Investigational Site 0015) | Recruiting |
| LaPorte, Indiana, United States, 46350 | |
| United States, Michigan | |
| Call for Information (Investigational Site 0012) | Recruiting |
| Kalamazoo, Michigan, United States, 49009 | |
| United States, North Carolina | |
| Call for Information (Investigational Site 0010) | Recruiting |
| Asheboro, North Carolina, United States, 27203 | |
| Call for Information (Investigational Site 0011) | Recruiting |
| Calabash, North Carolina, United States, 28467 | |
| United States, Ohio | |
| Call for Information (Investigational Site 0016) | Recruiting |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Oklahoma | |
| Call for Information (Investigational Site 0005) | Recruiting |
| Oklahoma City, Oklahoma, United States, 73139 | |
| United States, Oregon | |
| Call for Information (Investigational Site 0004) | Recruiting |
| Ashland, Oregon, United States, 97520 | |
| United States, Washington | |
| Call for Information (Investigational Site 0014) | Recruiting |
| Selah, Washington, United States, 98942 | |
| Korea, Republic of | |
| MSD Korea LTD | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Yong Soo (STEVE) Kim 82 2 331 2014 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01704261 History of Changes |
| Other Study ID Numbers: | 3102-022, 2012-002612-10 |
| Study First Received: | October 8, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Metformin Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013