Skip to main content
OpenTrials
Completed

NCT Number: NCT00086515

Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type II 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.

Inclusion criteria

  • Patients with type 2 diabetes mellitus

Treatment and study plan

Sitagliptin (MK0431)

Drug

Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104

Other names: MK0431, sitagliptin phosphate, Januvia

Placebo/Glipizide 5 mg

Drug

Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)

metformin

Drug

Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)

pioglitazone

Drug

Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)

Other names: ACTOS

Primary outcomes

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

    Time frame: Baseline and Week 24

    A1C is measured as a percent. Thus, this change from

    baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Secondary outcomes

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

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as FPG at

    Week 24 minus FPG at Week 0.

  2. Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at 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 Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Jul 5, 2004
Registry last updated
May 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.