Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313 AM1)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01709305
First received: October 16, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of participants receiving glimepiride added to sitagliptin and metformin combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Metformin Drug: Sitagliptin Drug: Acarbose Drug: Repaglinide Drug: Glimepiride Drug: Gliclazide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Active-Controlled, Open-label Clinical Trial to Evaluate the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose as a Third OAHA on Top of Sitagliptin+Metformin Combination Therapy in Chinese Patients With Type 2 Diabetes Mellitus (Phase IV; Protocol No. MK-0431-313-01) |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Acarbose
Glimepiride
Repaglinide
Sitagliptin
Sitagliptin phosphate
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2) [ Time Frame: Phase 2 Baseline (Week 20), Week 44 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2) [ Time Frame: Phase 2 Baseline (Week 20), Week 44 ] [ Designated as safety issue: Yes ]
- Number of Participants With Hypoglycemia Events (Phase 2) [ Time Frame: From Week 20 through Week 44 ] [ Designated as safety issue: Yes ]
- Number of Participants With Gastrointestinal Adverse Events (Phase 2) [ Time Frame: From Week 20 through Week 44 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 5500 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Metformin + Sitagliptin + Glimepiride
During Phase 2, participants receive up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Drug: Metformin
Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily
Other Names:
Drug: Sitagliptin
Sitagliptin, 100 mg oral tablet, once daily (QD)
Other Names:
Drug: Glimepiride
Glimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily)
Other Names:
|
|
Experimental: Metformin + Sitagliptin + Repaglinide
During Phase 2, participants receive up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Drug: Metformin
Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily
Other Names:
Drug: Sitagliptin
Sitagliptin, 100 mg oral tablet, once daily (QD)
Other Names:
Drug: Repaglinide
Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily)
Other Names:
|
|
Experimental: Metformin + Sitagliptin + Acarbose
During Phase 2, participants receive 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Drug: Metformin
Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily
Other Names:
Drug: Sitagliptin
Sitagliptin, 100 mg oral tablet, once daily (QD)
Other Names:
Drug: Acarbose
Acarbose, 50 mg oral tablets, TID (150 mg total daily dose)
Other Names:
|
|
Experimental: Metformin + Sitagliptin + Gliclazide
During Phase 2, participants receive 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Drug: Metformin
Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily
Other Names:
Drug: Sitagliptin
Sitagliptin, 100 mg oral tablet, once daily (QD)
Other Names:
Drug: Gliclazide
Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose)
Other Name: Diamicron MR™
|
Detailed Description:
Participants coming on study will be stabilized to a standardized metformin dose: this may take about 10 weeks, and then combination therapy with metformin + sitagliptin will begin during Phase 1 (Week 0 through Week 20). If a participant is already on a stabilized metformin dose, they will start immediately on combination therapy with metformin + sitagliptin for 20 weeks (Phase 1).
In Phase 2, participants who have failed to achieve adequate glycemic control (A1c ≥ 7% and ≤ 10% at Week 16 and fasting finger stick glucose ≥130 mg/dL and ≤280 mg/dL at Week 20) will be randomized to receive add-on therapy with glimepiride, repaglinide, acarbose, or gliclazide for 24 weeks (Week 20 through Week 44).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has Type 2 Diabetes Mellitus
- Agrees to use an effective method of contraception or must not otherwise be at risk of becoming pregnant (female participants)
Exclusion Criteria:
- Has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Has been treated with insulin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a Glucagon-like peptide-1 (GLP-1) mimetic or analogue before
- Is on a weight loss program (not in maintenance phase), has started a weight loss medication, or has undergone bariatric surgery within 12 months
- Has undergone a surgical procedure within 4 weeks
- Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder
- Has a medical history of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- Has poorly controlled hypertension
- Has severe peripheral vascular disease
- Has human immunodeficiency virus (HIV)
- Has had a clinically important hematological disorder
- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.
- Has a history of intolerance or hypersensitivity or any contraindication to study medications (including sitagliptin, metformin, glimepiride, repaglinide, acarbose or gliclazide) based upon the Chinese label
- Is on or likely to require treatment with ≥2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids (other than inhaled, nasal, or topical corticosteroids)
- Is pregnant or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug (female participants)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01709305 History of Changes |
| Other Study ID Numbers: | 0431-313 |
| Study First Received: | October 16, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Repaglinide Sitagliptin Gliclazide Metformin Acarbose Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013