A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01590771
First received: May 1, 2012
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Sitagliptin Drug: Placebo |
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 in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy, Alone or in Combination With Metformin |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Sulfonylurea Alone or in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone or in Combination with Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Plasma Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone or in Combination with Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Sulfonylurea in Combination wiht Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Plasma Glucose Levels at Week 24 in Participants Receiving Sulfonylurea Alone [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Plasma Glucose Levels at Week 24 in Participants Receiving Sulfonylurea in Combination With Metformin [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 460 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sitagliptin
All participants will be under treatment with a stable dose of sulfonylurea with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during part of the study.
|
Drug: Sitagliptin
Sitagliptin 100 mg once daily for 24 weeks
Other Names:
|
|
Placebo Comparator: Placebo
All participants will be under treatment with a stable dose of sulfonylurea with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during part of the study.
|
Drug: Placebo
Matching placebo once daily for 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- has T2DM
- is currently on a stable regimen of gliclazide or glimepiride, either alone or in combination with metformin for ≥ 10 weeks
- has a Visit 1/Screening HbA1C between 7.5% and 11.0%
- is a male, or a female who is highly unlikely to conceive during the study and for 14 days after the last dose of study medication
Exclusion Criteria:
- has a history of type 1 diabetes mellitus or a history of ketoacidosis
- has been treated with any antihyperglycemic therapies other than a sulfonylurea (alone or with metformin) within the prior 12 weeks or has ever been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic or analogue
- has a history of intolerance or hypersensitivity, or has any contraindication to sitagliptin, gliclazide/glimepiride, or metformin
- is on a weight loss program and not in the maintenance phase, or has started a weight loss medication or has undergone bariatric surgery within 12 months
- has undergone a surgical procedure within 4 weeks or has planned major surgery during the study
- has a medical history of active liver disease
- has had new or worsening signs or symptoms of coronary heart disease within the past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
- has a diagnosis of congestive heart failure with New York Heart Association Class III - IV cardiac status
- has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg
- has human immunodeficiency virus (HIV)
- has severe peripheral vascular disease
- is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
- has a history of malignancy ≤ 5 years before the study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- is pregnant or breast feeding, or is expecting to conceive or donate eggs during the study, including 14 days after the last dose of study medication
- is a user of recreational or illicit drugs or has had a recent history of drug abuse
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01590771 History of Changes |
| Other Study ID Numbers: | 0431-253 |
| Study First Received: | May 1, 2012 |
| Last Updated: | March 22, 2013 |
| Health Authority: | China: 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