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

Primary Purpose

Type 2 Diabetes Mellitus, Renal Impairment

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dutogliptin
dutogliptin
placebo
sitagliptin
sitagliptin
Sponsored by
Phenomix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, DPP4 inhibitor, dutogliptin, PHX1149

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phenomix Investigational Site 115
  • Phenomix Investigational Site 121
  • Phenomix Investigational Site 110
  • Phenomix Investigational Site 118
  • Phenomix Investigational Site 119
  • Phenomix Investigational Site 109
  • Phenomix Investigational Site 122
  • Phenomix Investigational Site 112
  • Phenomix Investigational Site 104
  • Phenomix Investigational Site 116
  • Phenomix Investigational Site 101
  • Phenomix Investigational Site 117
  • Phenomix Investigational Site 102
  • Phenomix Investigational Site 100
  • Phenomix Investigational Site 125
  • Phenomix Investigational Site 114
  • Phenomix Investigational Site 120
  • Phenomix Investigational Site 107
  • Phenomix Investigational Site 111
  • Phenomix Investigational Site 103
  • Phenomix Investigational Site 106
  • Phenomix Investigational Site 108
  • Phenomix Investigational Site 113
  • Phenomix Investigational Site 208
  • Phenomix Investigational Site 203
  • Phenomix Investigational Site 204
  • Phenomix Investigational Site 209
  • Phenomix Investigational Site 211
  • Phenomix Investigational Site 205
  • Phenomix Investigational Site 207
  • Phenomix Investigational Site 206
  • Phenomix Investigational Site 200
  • Phenomix Investigational Site 201
  • Phenomix Investigational Site 210
  • Phenomix Investigational Site 212
  • Phenomix Investigational Site 213
  • Phenomix Investigational Site 304
  • Phenomix Investigational Site 300
  • Phenomix Investigational Site 301
  • Phenomix Investigational Site 306
  • Phenomix Investigational Site 302
  • Phenomix Investigational Site 303
  • Phenomix Investigational Site 307

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Active Comparator

Arm Label

dutogliptin (double-blind, placebo-controlled period)

dutogliptin (single-blind, active-controlled period)

placebo (double-blind, placebo-controlled period)

placebo (single-blind, active-controlled period)

sitagliptin (single-blind, active-controlled period)

Arm Description

weeks 1-26

weeks 27-52

weeks 1-26

weeks 27-52

weeks 27-52

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of HbA1c
Change of fasting plasma glucose
Plasma dutogliptin levels
Per cent ex vivo DPP4 inhibition after drug dosing

Full Information

First Posted
August 12, 2009
Last Updated
February 1, 2010
Sponsor
Phenomix
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00958269
Brief Title
Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Technical/operational issues
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Phenomix
Collaborators
Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Renal Impairment
Keywords
diabetes, DPP4 inhibitor, dutogliptin, PHX1149

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dutogliptin (double-blind, placebo-controlled period)
Arm Type
Experimental
Arm Description
weeks 1-26
Arm Title
dutogliptin (single-blind, active-controlled period)
Arm Type
Experimental
Arm Description
weeks 27-52
Arm Title
placebo (double-blind, placebo-controlled period)
Arm Type
Placebo Comparator
Arm Description
weeks 1-26
Arm Title
placebo (single-blind, active-controlled period)
Arm Type
Placebo Comparator
Arm Description
weeks 27-52
Arm Title
sitagliptin (single-blind, active-controlled period)
Arm Type
Active Comparator
Arm Description
weeks 27-52
Intervention Type
Drug
Intervention Name(s)
dutogliptin
Intervention Description
100 mg QD
Intervention Type
Drug
Intervention Name(s)
dutogliptin
Intervention Description
200 mg QD
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
25 mg QD
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
50 mg QD
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change of HbA1c
Time Frame
Day 1 to Day 182
Title
Change of fasting plasma glucose
Time Frame
Day 1 to Day 182
Title
Plasma dutogliptin levels
Time Frame
Days 1, 198 and 182
Title
Per cent ex vivo DPP4 inhibition after drug dosing
Time Frame
Days 1, 98, and 182

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Phenomix Investigational Site 115
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Phenomix Investigational Site 121
City
Long Beach
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 110
City
Lynwood
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 118
City
Lynwood
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 119
City
Orange
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 109
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 122
City
Whittier
State/Province
California
Country
United States
Facility Name
Phenomix Investigational Site 112
City
Lauderdale Lakes
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 104
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 116
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Phenomix Investigational Site 101
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Phenomix Investigational Site 117
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Phenomix Investigational Site 102
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Phenomix Investigational Site 100
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Phenomix Investigational Site 125
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Phenomix Investigational Site 114
City
Springfield Gardens
State/Province
New York
Country
United States
Facility Name
Phenomix Investigational Site 120
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Phenomix Investigational Site 107
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Phenomix Investigational Site 111
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Phenomix Investigational Site 103
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 106
City
Houston
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 108
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Phenomix Investigational Site 113
City
Alexandria
State/Province
Virginia
Country
United States
Facility Name
Phenomix Investigational Site 208
City
Kemerovo
Country
Russian Federation
Facility Name
Phenomix Investigational Site 203
City
Moscow
Country
Russian Federation
Facility Name
Phenomix Investigational Site 204
City
Moscow
Country
Russian Federation
Facility Name
Phenomix Investigational Site 209
City
Moscow
Country
Russian Federation
Facility Name
Phenomix Investigational Site 211
City
Moscow
Country
Russian Federation
Facility Name
Phenomix Investigational Site 205
City
Novosibirsk
Country
Russian Federation
Facility Name
Phenomix Investigational Site 207
City
Perm.
Country
Russian Federation
Facility Name
Phenomix Investigational Site 206
City
Petrozavodsk
Country
Russian Federation
Facility Name
Phenomix Investigational Site 200
City
St. Petersburg
Country
Russian Federation
Facility Name
Phenomix Investigational Site 201
City
St. Petersburg
Country
Russian Federation
Facility Name
Phenomix Investigational Site 210
City
St. Petersburg
Country
Russian Federation
Facility Name
Phenomix Investigational Site 212
City
St. Petersburg
Country
Russian Federation
Facility Name
Phenomix Investigational Site 213
City
St. Petersburg
Country
Russian Federation
Facility Name
Phenomix Investigational Site 304
City
Chernivtsi
Country
Ukraine
Facility Name
Phenomix Investigational Site 300
City
Kyiv
Country
Ukraine
Facility Name
Phenomix Investigational Site 301
City
Kyiv
Country
Ukraine
Facility Name
Phenomix Investigational Site 306
City
Kyiv
Country
Ukraine
Facility Name
Phenomix Investigational Site 302
City
Odesa
Country
Ukraine
Facility Name
Phenomix Investigational Site 303
City
Vinnytsa
Country
Ukraine
Facility Name
Phenomix Investigational Site 307
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

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

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