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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo- and Sitagliptin-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment Including Subjects on Hemodialysis

Conditions
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Type 2 Diabetes Mellitus, Renal Impairment

Intervention / Treatment
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* Drug: dutogliptin
* Drug: dutogliptin
* Drug: placebo
* Drug: sitagliptin
* Drug: sitagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dutogliptin (double-blind, placebo-controlled period)<br>weeks 1-26 | Drug: dutogliptin<br>* 100 mg QD<br>Drug: dutogliptin<br>* 200 mg QD<br>|
| Experimental: dutogliptin (single-blind, active-controlled period)<br>weeks 27-52 | Drug: dutogliptin<br>* 100 mg QD<br>Drug: dutogliptin<br>* 200 mg QD<br>|
| Placebo Comparator: placebo (double-blind, placebo-controlled period)<br>weeks 1-26 | Drug: placebo<br> <br> |
| Placebo Comparator: placebo (single-blind, active-controlled period)<br>weeks 27-52 | Drug: placebo<br> <br> |
| Active Comparator: sitagliptin (single-blind, active-controlled period)<br>weeks 27-52 | Drug: sitagliptin<br>* 25 mg QD<br>Drug: sitagliptin<br>* 50 mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, DPP4 inhibitor, dutogliptin, PHX1149