- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00449930
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
April 5, 2017 updated by: Merck Sharp & Dohme LLC
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1050
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
General Inclusion Criteria:
- Patient has type 2 diabetes mellitus (T2DM)
- Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy
General Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Drug
|
(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
Other Names:
|
Active Comparator: 2
Active comparator
|
(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time Frame: Baseline and 24 weeks
|
HbA1c is measured as a percent.
Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
|
Baseline and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2007
Primary Completion (Actual)
July 25, 2008
Study Completion (Actual)
July 25, 2008
Study Registration Dates
First Submitted
March 19, 2007
First Submitted That Met QC Criteria
March 19, 2007
First Posted (Estimate)
March 21, 2007
Study Record Updates
Last Update Posted (Actual)
May 11, 2017
Last Update Submitted That Met QC Criteria
April 5, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Sitagliptin Phosphate
Other Study ID Numbers
- 0431-049
- MK0431-049
- 2006_561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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