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Completed

NCT Number: NCT00837577

MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 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.

Inclusion criteria

  • Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Exclusion criteria

  • Patients Have A History Of Type 1 Diabetes Mellitus

Treatment and study plan

Comparator: placebo

Drug

Placebo to sitagliptin once daily for 12 weeks (double-blind period)

Sitagliptin

Drug

Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).

Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.

Other names: Januvia, MK0431, ONO-5435

Voglibose

Drug

All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

    Time frame: Baseline and Week 12

    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).

Secondary outcomes

  1. Change From Baseline in 2-hour Postprandial Glucose at Week 12

    Time frame: Baseline and Week 12

    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

    Time frame: Baseline and Week 12

    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 5, 2009
Registry last updated
May 15, 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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