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

NCT00958269 | Terminated Phase 3

• 1 other identifier: PHX1149-PROT306
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 43

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.

Conditions

Type 2 Diabetes Mellitus; Renal Impairment

Keywords

diabetes; DPP4 inhibitor; dutogliptin; PHX1149

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (5)

dutogliptin (double-blind, placebo-controlled period)

EXPERIMENTAL

weeks 1-26

Drug: dutogliptin

dutogliptin (single-blind, active-controlled period)

EXPERIMENTAL

weeks 27-52

Drug: dutogliptin

placebo (double-blind, placebo-controlled period)

PLACEBO COMPARATOR

weeks 1-26

Drug: placebo

placebo (single-blind, active-controlled period)

PLACEBO COMPARATOR

weeks 27-52

Drug: placebo

sitagliptin (single-blind, active-controlled period)

ACTIVE COMPARATOR

weeks 27-52

Drug: sitagliptin

Interventions

dutogliptin DRUG

100 mg QD

dutogliptin (double-blind, placebo-controlled period); dutogliptin (single-blind, active-controlled period)

placebo DRUG

placebo (double-blind, placebo-controlled period); placebo (single-blind, active-controlled period)

sitagliptin DRUG

25 mg QD

sitagliptin (single-blind, active-controlled period)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
• Kidney transplant

Sponsors & Collaborators

• Phenomix: lead
• Forest Laboratories: collaborator

Study Sites (43)

Phenomix Investigational Site 115

Tempe, Arizona, United States

Location

Phenomix Investigational Site 121

Long Beach, California, United States

Location

Phenomix Investigational Site 110

Lynwood, California, United States

Location

Phenomix Investigational Site 118

Lynwood, California, United States

Location

Phenomix Investigational Site 119

Orange, California, United States

Location

Phenomix Investigational Site 109

Palm Springs, California, United States

Location

Phenomix Investigational Site 122

Whittier, California, United States

Location

Phenomix Investigational Site 112

Lauderdale Lakes, Florida, United States

Location

Phenomix Investigational Site 104

Ocala, Florida, United States

Location

Phenomix Investigational Site 116

Pembroke Pines, Florida, United States

Location

Phenomix Investigational Site 101

Augusta, Georgia, United States

Location

Phenomix Investigational Site 117

Honolulu, Hawaii, United States

Location

Phenomix Investigational Site 102

Baton Rouge, Louisiana, United States

Location

Phenomix Investigational Site 100

Rockville, Maryland, United States

Location

Phenomix Investigational Site 125

Rockville, Maryland, United States

Location

Phenomix Investigational Site 114

Springfield Gardens, New York, United States

Location

Phenomix Investigational Site 120

Winston-Salem, North Carolina, United States

Location

Phenomix Investigational Site 107

Columbia, South Carolina, United States

Location

Phenomix Investigational Site 111

Nashville, Tennessee, United States

Location

Phenomix Investigational Site 103

Fort Worth, Texas, United States

Location

Phenomix Investigational Site 106

Houston, Texas, United States

Location

Phenomix Investigational Site 108

San Antonio, Texas, United States

Location

Phenomix Investigational Site 113

Alexandria, Virginia, United States

Location

Phenomix Investigational Site 208

Kemerovo, Russia

Location

Phenomix Investigational Site 203

Moscow, Russia

Location

Phenomix Investigational Site 204

Moscow, Russia

Location

Phenomix Investigational Site 209

Moscow, Russia

Location

Phenomix Investigational Site 211

Moscow, Russia

Location

Phenomix Investigational Site 205

Novosibirsk, Russia

Location

Phenomix Investigational Site 207

Perm, Russia

Location

Phenomix Investigational Site 206

Petrozavodsk, Russia

Location

Phenomix Investigational Site 200

Saint Petersburg, Russia

Location

Phenomix Investigational Site 201

Saint Petersburg, Russia

Location

Phenomix Investigational Site 210

Saint Petersburg, Russia

Location

Phenomix Investigational Site 212

Saint Petersburg, Russia

Location

Phenomix Investigational Site 213

Saint Petersburg, Russia

Location

Phenomix Investigational Site 304

Chernivtsi, Ukraine

Location

Phenomix Investigational Site 300

Kyiv, Ukraine

Location

Phenomix Investigational Site 301

Kyiv, Ukraine

Location

Phenomix Investigational Site 306

Kyiv, Ukraine

Location

Phenomix Investigational Site 302

Odesa, Ukraine

Location

Phenomix Investigational Site 303

Vinnytsa, Ukraine

Location

Phenomix Investigational Site 307

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency; Diabetes Mellitus

Interventions

dutogliptin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

UA (7); US (23); RU (13)