A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00541450
First received: October 5, 2007
Last updated: March 11, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Comparator: sitagliptin phosphate (sitagliptin) Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: pioglitazone Drug: Matching placebo to pioglitazone Drug: Matching placebo to sitagliptin Drug: Matching Placebo to Sita/Met FDC |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Pioglitazone
Pioglitazone hydrochloride
Sitagliptin
Sitagliptin phosphate
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks [ Time Frame: Baseline to 40 weeks ] [ Designated as safety issue: No ]The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.
- Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.
Secondary Outcome Measures:
- Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks [ Time Frame: Baseline and 40 weeks ] [ Designated as safety issue: No ]The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.
- Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
- Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks [ Time Frame: Baseline and 40 weeks ] [ Designated as safety issue: No ]The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.
- Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
| Enrollment: | 492 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sita/Met FDC
In Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks. In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone. |
Drug: Comparator: sitagliptin phosphate (sitagliptin)
sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period
Other Name: MK0431, Januvia™
Drug: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period
Other Name: MK-0431A, Janumet™
Drug: Matching placebo to pioglitazone
matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period. Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks. |
|
Active Comparator: Pioglitazone
In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d. In Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks). |
Drug: Comparator: pioglitazone
pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.
Other Name: Actos®
Drug: Matching placebo to sitagliptin
matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.
Drug: Matching Placebo to Sita/Met FDC
matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).
|
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients between the ages of 18 and 78 with type 2 diabetes mellitus
- Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00541450 History of Changes |
| Other Study ID Numbers: | MK-0431-068, 2007_501 |
| Study First Received: | October 5, 2007 |
| Results First Received: | January 13, 2011 |
| Last Updated: | March 11, 2011 |
| 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 Pioglitazone 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 June 18, 2013