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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00958269
• Other study ID #: PHX1149-PROT306
• Status: Terminated
• Phase: Phase 3
• First received: August 12, 2009
• Last updated: February 1, 2010
• Start date: August 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2010
• Source: Phenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Impairment
• Renal Insufficiency
• Type 2 Diabetes Mellitus

Intervention

Drug:
• dutogliptin
100 mg QD
• dutogliptin
200 mg QD
• placebo

• sitagliptin
25 mg QD
• sitagliptin
50 mg QD

Locations

Country	Name	City	State
Russian Federation	Phenomix Investigational Site 208	Kemerovo
Russian Federation	Phenomix Investigational Site 203	Moscow
Russian Federation	Phenomix Investigational Site 204	Moscow
Russian Federation	Phenomix Investigational Site 209	Moscow
Russian Federation	Phenomix Investigational Site 211	Moscow
Russian Federation	Phenomix Investigational Site 205	Novosibirsk
Russian Federation	Phenomix Investigational Site 207	Perm.
Russian Federation	Phenomix Investigational Site 206	Petrozavodsk
Russian Federation	Phenomix Investigational Site 200	St. Petersburg
Russian Federation	Phenomix Investigational Site 201	St. Petersburg
Russian Federation	Phenomix Investigational Site 210	St. Petersburg
Russian Federation	Phenomix Investigational Site 212	St. Petersburg
Russian Federation	Phenomix Investigational Site 213	St. Petersburg
Ukraine	Phenomix Investigational Site 304	Chernivtsi
Ukraine	Phenomix Investigational Site 300	Kyiv
Ukraine	Phenomix Investigational Site 301	Kyiv
Ukraine	Phenomix Investigational Site 306	Kyiv
Ukraine	Phenomix Investigational Site 302	Odesa
Ukraine	Phenomix Investigational Site 303	Vinnytsa
Ukraine	Phenomix Investigational Site 307	Zaporizhzhya
United States	Phenomix Investigational Site 113	Alexandria	Virginia
United States	Phenomix Investigational Site 101	Augusta	Georgia
United States	Phenomix Investigational Site 102	Baton Rouge	Louisiana
United States	Phenomix Investigational Site 107	Columbia	South Carolina
United States	Phenomix Investigational Site 103	Fort Worth	Texas
United States	Phenomix Investigational Site 117	Honolulu	Hawaii
United States	Phenomix Investigational Site 106	Houston	Texas
United States	Phenomix Investigational Site 112	Lauderdale Lakes	Florida
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 111	Nashville	Tennessee
United States	Phenomix Investigational Site 104	Ocala	Florida
United States	Phenomix Investigational Site 119	Orange	California
United States	Phenomix Investigational Site 109	Palm Springs	California
United States	Phenomix Investigational Site 116	Pembroke Pines	Florida
United States	Phenomix Investigational Site 100	Rockville	Maryland
United States	Phenomix Investigational Site 125	Rockville	Maryland
United States	Phenomix Investigational Site 108	San Antonio	Texas
United States	Phenomix Investigational Site 114	Springfield Gardens	New York
United States	Phenomix Investigational Site 115	Tempe	Arizona
United States	Phenomix Investigational Site 122	Whittier	California
United States	Phenomix Investigational Site 120	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Phenomix	Forest Laboratories

Countries where clinical trial is conducted

United States,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Change of HbA1c		Day 1 to Day 182	No
Secondary	Change of fasting plasma glucose		Day 1 to Day 182	No
Secondary	Plasma dutogliptin levels		Days 1, 198 and 182	No
Secondary	Per cent ex vivo DPP4 inhibition after drug dosing		Days 1, 98, and 182	No