Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Non-Insulin-Dependent
Intervention: Janumet/MK0431A (sitagliptin phosphate (+) metformin hydrochloride) (Drug); Comparator: glimepiride (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
This study will assess the effect of Janumet (MK0431A) compared with the effect of
glimepiride on HbA1c.
Clinical Details
Official title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in HbA1c at Week 30
Secondary outcome: Change from baseline in fasting plasma glucose (FPG) at Week 30Number of patients with hypoglycemic events The change from baseline in body weight at Week 30 Number of patients with HbA1c < 7.0% at Week 30
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient Has T2DM
- Patient Is Currently Not On An Aha (Off For At Least 12 Weeks) And Has A Visit
1/Screening Visit Hba1c Greater Than Or Equal To 7. 0% And Less Than Or Equal To 9. 5%
Or Patient Is Currently On Aha Monotherapy Or Low-Dose (I. E., Less Than Or Equal To
50% Maximum Labeled Dose Of Each Agent) Oral Combination Therapy And Has A Visit
1/Screening Visit Hba1c Greater Than Or Equal To 6. 5% And Less Than Or Equal To 9. 0%
Exclusion Criteria:
- Patient Has A History Of Type 1 Diabetes Mellitus Or A History Of Ketoacidosis
- Patient Has Been On An Investigational Or Approved Glp-1 Analogues (E. G., Byetta), Or
A PparĪ± Agonist Agent (E. G., Tzd Such As Rosiglitazone Or Pioglitazone) Within 12
Weeks Of Visit 1
- Patient Required Insulin Within The Prior 12 Weeks
Locations and Contacts
Additional Information
Starting date: December 2009
Ending date: February 2012
Last updated: October 14, 2009
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