Status:
TERMINATED
Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
Lead Sponsor:
Phenomix
Collaborating Sponsors:
Forest Laboratories
Conditions:
Type 2 Diabetes Mellitus
Renal Impairment
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- Renal impairment (moderate and severe)
- Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
- HbA1c 7.0% - 10.5%, inclusive
- Male or female subjects between the ages of 18 and 85 years, inclusive.
Exclusion
- Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
- Kidney transplant
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00958269
Start Date
August 1 2009
End Date
November 1 2011
Last Update
February 3 2010
Active Locations (43)
Enter a location and click search to find clinical trials sorted by distance.
1
Phenomix Investigational Site 115
Tempe, Arizona, United States
2
Phenomix Investigational Site 121
Long Beach, California, United States
3
Phenomix Investigational Site 110
Lynwood, California, United States
4
Phenomix Investigational Site 118
Lynwood, California, United States