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)

NCT ID: NCT00541450

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 492 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-15
• Study Completion Date: 2010-01-16

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comparator: sitagliptin phosphate (sitagliptin)

Intervention Type: DRUG

sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period

sitagliptin phosphate (+) metformin hydrochloride

Intervention Type: DRUG

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

Matching placebo to pioglitazone

Intervention Type: DRUG

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.

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).

Group Type: ACTIVE_COMPARATOR

Comparator: pioglitazone

Intervention Type: DRUG

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.

Matching placebo to sitagliptin

Intervention Type: DRUG

matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.

Matching Placebo to Sita/Met FDC

Intervention Type: DRUG

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).

Interventions

Comparator: sitagliptin phosphate (sitagliptin)

sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Matching placebo to sitagliptin

matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

MK0431, Januvia™; MK-0431A, Janumet™; Actos®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Perez-Monteverde A, Seck T, Xu L, Lee MA, Sisk CM, Williams-Herman DE, Engel SS, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.x.

Reference Type: RESULT

PMID: 21849007 (View on PubMed)

Other Identifiers

2007_501

Identifier Type: -

Identifier Source: secondary_id

0431-068

Identifier Type: -

Identifier Source: org_study_id