Initial Combination With Pioglitazone Study (0431-064)

NCT00397631 | Completed Phase 3 Results

• 3 other identifiers: 0431-064MK0431-0642006_531
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

  HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

  Baseline and 24 weeks

Secondary Outcomes (2)

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

  Baseline and Week 24

• Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24

  Baseline and Week 24

Study Arms (2)

1

EXPERIMENTAL

sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.

Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d

2

ACTIVE COMPARATOR

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.

Interventions

sitagliptin 100 mg q.d./pioglitazone 30 mg q.d DRUG

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.

1

Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. DRUG

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.

2

Eligibility Criteria

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

You may qualify if:

• Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011 Feb;65(2):154-64. doi: 10.1111/j.1742-1241.2010.02589.x.

  PMID: 21235696 RESULT

• Yoon KH, Steinberg H, Teng R, Golm GT, Lee M, O'Neill EA, Kaufman KD, Goldstein BJ. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012 Aug;14(8):745-52. doi: 10.1111/j.1463-1326.2012.01594.x. Epub 2012 Apr 17.

  PMID: 22405352 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

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: November 8, 2006
• First Posted: November 9, 2006
• Study Start: December 19, 2006
• Primary Completion: June 28, 2008
• Study Completion: June 28, 2008
• Last Updated: May 12, 2017
• Results First Posted: July 10, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share