Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phenomix
• Collaborator: Forest Laboratories
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)

• Kidney transplant