A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170 AM1)
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Purpose
The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin monotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Metformin Drug: Sitagliptin / Metformin Drug: Placebo to Metformin Drug: Placebo to Sitagliptin / Metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients With Type 2 Diabetes Mellitus |
- Change from baseline in Hemoglobin A1c (A1C) at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
- Number of participants with adverse events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 240 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sitagliptin / Metformin
Sitagliptin/metformin: 50/500, 50/850, or 50/1000 mg and placebo to metformin twice daily
|
Drug: Sitagliptin / Metformin
Sitagliptin / metformin oral tablet 50/500, 50/850, or 50/1000 mg dosed twice daily. After the single blind 1-week run-in period patients will be randomized to receive sitagliptin/metformin combination: 50/500, 50/850, or 50/1000 mg twice a day plus placebo to metformin or Metformin 500, 850, or 1000 mg twice a day, plus placebo to sitagliptin/metformin combination. Other Names:
Drug: Placebo to Metformin
Matching placebo to Metformin twice a day Participants randomized to sitagliptin / metformin combination will take matching placebo to metformin twice a day for 20 weeks. |
|
Active Comparator: Metformin
Metformin 500, 850, or 1000 mg and placebo to sitagliptin /metformin twice daily
|
Drug: Metformin
Metformin oral tablets twice a day Participants on a metformin daily dose of 1000, 1250, or 1275 mg at screening will be switched to a metformin daily dose of 1000 mg (500 mg twice a day); 1500, 1700, or 1750 mg will be switched to a metformin daily dose of 1700 mg (850 mg twice a day); 2000 mg or more will be switched to a metformin daily dose of 2000 mg (1000 mg twice a day). Once these adjustments are made participants will enter a 1-week single blind run-in followed by a 20-week treatment period. Total treatment with metformin will be 21 weeks. Other Name: Glucophage
Drug: Placebo to Sitagliptin / Metformin
Matching placebo to Sitagliptin / Metformin oral tablet dosed twice daily During the 1-week single blind run-in all participants will take the matching placebo to sitagliptin/metformin combination twice a day. Following randomization participants assigned to metformin treatment arm will take the placebo to sitagliptin/metformin combination twice a day for 20 weeks. |
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Has Type 2 Diabetes Mellitus (T2DM)
- Has not received treatment with insulin for at least 6 months prior to the Screening Visit/Visit 1.
- A1C greater than or equal to 7.0% and less than or equal to 10.0% on metformin, greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. NOTE: Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated.
- Between 10 and 17 years of age on day of signing informed consent with randomization to occur prior to 18th birthday.
- Participant and a family member or adult closely involved in the daily activities will participate in the participant's treatment and study protocol (i.e., available for telephone calls, study visits and administration of study medication as needed).
Exclusion Criteria:
- Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes).
- Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
- Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent.
- Participant has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin,alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide).
- Exhibits abnormal growth patterns or is being treated with growth hormone.
- History of idiopathic acute pancreatitis or chronic pancreatitis.
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
Show 31 Study Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01472367 History of Changes |
| Other Study ID Numbers: | 0431A-170 |
| Study First Received: | November 11, 2011 |
| Last Updated: | May 13, 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 Sitagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013