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
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: 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 July 22, 2014