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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01034111
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : November 7, 2011
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin phosphate Drug: Metformin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 1, 2010
Actual Primary Completion Date : October 4, 2010
Actual Study Completion Date : October 4, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment [ Time Frame: 4 weeks ]
    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 :
  1. Change From Baseline in Fasting Plasma Glucose at Week 4 [ Time Frame: Baseline and Week 4 ]
    Calculated as the mean change from baseline in fasting plasma glucose at Week 4.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01034111

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01034111     History of Changes
Other Study ID Numbers: 0431-178
First Posted: December 17, 2009    Key Record Dates
Results First Posted: November 7, 2011
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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