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Completed

NCT Number: NCT00397631

Initial Combination With Pioglitazone Study (0431-064)

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline and 24 weeks

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

Secondary outcomes

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

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

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

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 9, 2006
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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