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)

NCT00541450 | Completed Phase 3 Results

• 2 other identifiers: 0431-0682007_501
• Study Type: interventional
• Target: 492
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks

  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.

  Baseline to 40 weeks

• Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

  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.

  Baseline to 12 weeks

Secondary Outcomes (4)

• Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks

  Baseline and 40 weeks

• Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

  Baseline to 12 weeks

• Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks

  Baseline and 40 weeks

• Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

  Baseline to 12 weeks

Study Arms (2)

Sita/Met FDC

EXPERIMENTAL

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); Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: Matching placebo to pioglitazone

Pioglitazone

ACTIVE COMPARATOR

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; Drug: Matching placebo to sitagliptin; Drug: Matching Placebo to Sita/Met FDC

Interventions

Comparator: sitagliptin phosphate (sitagliptin) DRUG

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

Also known as: MK0431, Januvia™

Sita/Met FDC

sitagliptin phosphate (+) metformin hydrochloride 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

Also known as: MK-0431A, Janumet™

Sita/Met FDC

Comparator: pioglitazone 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.

Also known as: Actos®

Pioglitazone

Matching placebo to pioglitazone 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.

Sita/Met FDC

Matching placebo to sitagliptin DRUG

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

Pioglitazone

Matching Placebo to Sita/Met FDC 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).

Pioglitazone

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21849007 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations; Thiazolidinediones; Thiazoles; Sulfur Compounds

Results Point of Contact

• Title: Vice President of Late Stage Development
• Organization: Merck Sharp & Dohme Corp

clinicaltrialsdisclosure@spcorp.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: January 15, 2008
• Primary Completion: January 8, 2010
• Study Completion: January 16, 2010
• Last Updated: May 12, 2017
• Results First Posted: April 14, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share