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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00837577
First received: February 3, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Comparator: Placebo
Drug: Sitagliptin
Drug: Voglibose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change From Baseline in 2-hour Postprandial Glucose at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.


Enrollment: 133
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin/Sitagliptin Drug: Sitagliptin

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
Drug: Voglibose

All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Experimental: Placebo/Sitagliptin Drug: Comparator: Placebo
Placebo to sitagliptin once daily for 12 weeks (double-blind period)
Drug: Sitagliptin

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
Drug: Voglibose

All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837577

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00837577     History of Changes
Other Study ID Numbers: 0431-104, 2009_535
Study First Received: February 3, 2009
Results First Received: August 9, 2011
Last Updated: July 3, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Voglibose
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014