Initial Combination With Pioglitazone Study
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00397631
First received: November 8, 2006
Last updated: April 20, 2010
Last verified: April 2010
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Purpose
A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. |
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 Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Drug Information available for:
Pioglitazone
Pioglitazone hydrochloride
Sitagliptin
Sitagliptin phosphate
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Secondary Outcome Measures:
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
- Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
| Enrollment: | 520 |
| Study Start Date: | December 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
|
Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d
Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.
|
|
Active Comparator: 2
sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d.
|
Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
General Inclusion Criteria:
- Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)
General Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
- Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years
Contacts and Locations More Information
Additional Information:
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00397631 History of Changes |
| Other Study ID Numbers: | 2006_531, MK0431-064 |
| Study First Received: | November 8, 2006 |
| Results First Received: | May 19, 2009 |
| Last Updated: | April 20, 2010 |
| 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 |
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 19, 2013