Phase 4
Completed N=5,570
A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
Source: ClinicalTrials.gov NCT01709305 ↗Enrolled (actual)
5,570
Serious AEs
1.3%
Results posted
May 2016
Primary outcomePrimary: Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2) — -0.65; -0.62; -0.46; -0.69 Percent
◆ Published Evidence
Emerging
14citations · ~2 / year
Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial.
Summary
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. The study would be declared successful if at least one of the three primary hypotheses was met.
Linked Publications
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Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2) |
-0.65; -0.62; -0.46; -0.69 | — |
| SECONDARY Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2) |
0.4; 0.2; -0.9; 0.2 | — |
| SECONDARY Percentage of Participants With Hypoglycemia Events (Phase 2) |
8.9; 6.1; 0.5; 3.6 | <0.001 sig |
| SECONDARY Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2) |
0; 0; 0.4; 0.2 | 0.158 |
| SECONDARY Percentage of Participants With a GI AE of Vomiting (Phase 2) |
0.2; 0; 0.2; 0.2 | 0.998 |
| SECONDARY Percentage of Participants With a GI AE of Diarrhea (Phase 2) |
0.5; 0.4; 0.4; 0.9 | 0.651 |
| SECONDARY Percentage of Participants With a GI AE of Abdominal Pain (Phase 2) |
0; 0; 0.4; 0.2 | 0.158 |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01709305) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.