Renal Impairment, Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, DPP4 inhibitor, dutogliptin, PHX1149
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.
Interventions
Sponsors
Forest Laboratories
Phenomix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs | Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study) |
Secondary
| Measure | Time frame |
|---|---|
| Change of HbA1c | Day 1 to Day 182 |
| Change of fasting plasma glucose | Day 1 to Day 182 |
| Plasma dutogliptin levels | Days 1, 198 and 182 |
| Per cent ex vivo DPP4 inhibition after drug dosing | Days 1, 98, and 182 |
Countries
Russia, Ukraine, United States
Outcome results
None listed