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Completed

NCT Number: NCT00532935

MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

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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–78 year

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:

  • Patient has type 2 diabetes mellitus
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

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 12 weeks
  • Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Treatment and study plan

sitagliptin phosphate (+) metformin hydrochloride

Drug

sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period

Other names: Janumet

Comparator: pioglitazone

Drug

pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.

Other names: pioglitazone

Primary outcomes

  1. Change From Baseline in A1C at Week 32

    Time frame: Baseline and Week 32

    A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

Secondary outcomes

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

    Time frame: Baseline and Week 1

    Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone

  2. Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32

    Time frame: Baseline and Week 32

    Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG

  3. Change From Baseline in FPG at Week 32

    Time frame: Baseline and Week 32

    Change from baseline reflects the Week 32 FPG minus the baseline FPG

  4. Percent of Participants With A1C <7.0% at Week 32

    Time frame: Week 32

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2007
Registry last updated
Jun 9, 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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