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

Phase 3TerminatedNCT00958269

Phenomix360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

360

Conditions

Type 2 Diabetes Mellitus Renal Impairment

Interventions

dutogliptinDRUG

100 mg QD

dutogliptinDRUG

200 mg QD

placeboDRUG

sitagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs

Time frame: 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 Outcomes

Change of HbA1c

Time frame: Day 1 to Day 182

Change of fasting plasma glucose

Time frame: Day 1 to Day 182

Plasma dutogliptin levels

Time frame: Days 1, 198 and 182

Per cent ex vivo DPP4 inhibition after drug dosing

Time frame: Days 1, 98, and 182

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Phenomix Investigational Site 115

Tempe, Arizona, United States

Phenomix Investigational Site 121

Long Beach, California, United States

Phenomix Investigational Site 110

Lynwood, California, United States

Phenomix Investigational Site 118

Lynwood, California, United States

Phenomix Investigational Site 119

Orange, California, United States

Phenomix Investigational Site 109

Palm Springs, California, United States

Phenomix Investigational Site 122

Whittier, California, United States

Phenomix Investigational Site 112

Lauderdale Lakes, Florida, United States

Phenomix Investigational Site 104

Ocala, Florida, United States

Phenomix Investigational Site 116

Pembroke Pines, Florida, United States

...and 33 more locations