- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00094770
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
August 25, 2016 updated by: Merck Sharp & Dohme LLC
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The duration of treatment is 104 weeks.
Study Type
Interventional
Enrollment (Actual)
1172
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
Inclusion Criteria:
- Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
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: Sitagliptin 100 mg
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
|
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Other Names:
|
Active Comparator: Glipizide
Glipizide 1 tablet (5 mg) per day.
Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
Glipizide 1 tablet (5 mg) per day.
Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c at Week 52
Time Frame: Baseline and Week 52
|
HbA1c is measured as percent.
Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
|
Baseline and Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c at Week 104
Time Frame: Baseline and Week 104
|
HbA1c is measured as percent.
Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
|
Baseline and Week 104
|
Change From Baseline in Body Weight at Week 52
Time Frame: Baseline and Week 52
|
Change from baseline at Week 52 is defined as Week 52 minus Week 0.
|
Baseline and Week 52
|
Change From Baseline in Body Weight at Week 104
Time Frame: Baseline and Week 104
|
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
|
Baseline and Week 104
|
Hypoglycemic Events at Week 52
Time Frame: Baseline to Week 52
|
Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
|
Baseline to Week 52
|
Hypoglycemic Events at Week 104
Time Frame: Baseline to Week 104
|
Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
|
Baseline to Week 104
|
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
Time Frame: Baseline to Week 104
|
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
|
Baseline to Week 104
|
Number of Participants With Serious CAEs at Week 104
Time Frame: Baseline to Week 104
|
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
|
Baseline to Week 104
|
Number of Participants With Drug-related CAEs at Week 104
Time Frame: Baseline to Week 104
|
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
|
Baseline to Week 104
|
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
Time Frame: Baseline to Week 104
|
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
|
Baseline to Week 104
|
Number of Participants With Serious LAEs at Week 104
Time Frame: Baseline to Week 104
|
Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
|
Baseline to Week 104
|
Number of Participants With Drug-related LAEs at Week 104
Time Frame: Baseline to Week 104
|
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.
|
Baseline to Week 104
|
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.
General Publications
- Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30. Erratum In: Diabetes Ther. 2015 Mar;6(1):97-8.
- Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
- Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. doi: 10.1016/j.diabres.2011.03.006. Epub 2011 Apr 8.
- Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76. doi: 10.1111/j.1742-1241.2010.02353.x.
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
September 1, 2004
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
October 22, 2004
First Submitted That Met QC Criteria
October 22, 2004
First Posted (Estimate)
October 25, 2004
Study Record Updates
Last Update Posted (Estimate)
August 26, 2016
Last Update Submitted That Met QC Criteria
August 25, 2016
Last Verified
August 1, 2016
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
- Sitagliptin Phosphate
- Glipizide
Other Study ID Numbers
- 0431-024
- MK0431-024
- 2004_049
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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