Initial Combination With Pioglitazone Study (0431-064)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and Week 24
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 19, 2006
• Primary Completion (ACTUAL): June 28, 2008
• Study Completion (ACTUAL): June 28, 2008

Study Registration Dates

• First Submitted: November 8, 2006
• First Submitted That Met QC Criteria: November 8, 2006
• First Posted (ESTIMATE): November 9, 2006

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Pioglitazone; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-064; MK0431-064; 2006_531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php