A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01034111
First received: December 16, 2009
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.


Condition Intervention Phase
Type 2 Diabetes
Drug: Sitagliptin phosphate
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Calculated as the mean change from baseline in fasting plasma glucose at Week 4.


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin as add-on therapy to a stable dose of metformin
Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
Other Names:
  • MK-0431
  • Januvia
Drug: Metformin
Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Other Name: Glucophage

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with T2DM failing metformin monotherapy
  • Between the ages of 18 and 79

Exclusion Criteria:

  • Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034111

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01034111     History of Changes
Other Study ID Numbers: 0431-178, 2009_705
Study First Received: December 16, 2009
Results First Received: October 3, 2011
Last Updated: August 29, 2013
Health Authority: Vietnam: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014