Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

NCT00850239 | Terminated Phase 3

• 1 other identifier: PHX1149-PROT302
• Study Type: interventional
• Target: 700
• Locations: 7 countries
• Sites: 97

Brief Summary

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; DPP4 inhibitor; dutogliptin

Outcome Measures

Primary Outcomes (1)

• Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.

  26 weeks

Secondary Outcomes (2)

• Demonstrate safety and tolerability of dutogliptin

  26 weeks

• • Demonstrate changes in fasting plasma glucose

  26 weeks

Study Arms (2)

1

EXPERIMENTAL

dutogliptin/PHX1149T

Drug: dutogliptin

2

PLACEBO COMPARATOR

Plabeco

Drug: placebo

Interventions

dutogliptin DRUG

400 mg

Also known as: PHX1149T

1

placebo DRUG

2

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, diagnosed at least 4 months prior to Screening (Visit 1)
• Age 18 to 85 years, inclusive.
• Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
• Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
• HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (\> 0.8 ng/mL; \> 281 pmol/L) at screening (Visit 1)

You may not qualify if:

• Type 1 diabetes mellitus

Sponsors & Collaborators

• Phenomix: lead
• Forest Laboratories: collaborator

Study Sites (97)

Phenomix Investigational Site 115

Montgomery, Alabama, United States

Location

Phenomix Investigational Site 121

Tempe, Arizona, United States

Location

Phenomix Investigational Site 137

Tempe, Arizona, United States

Location

Phenomix Investigational Site 105

Anaheim, California, United States

Location

Phenomix Investigational Site 123

Chico, California, United States

Location

Phenomix Investigational Site 134

Escondido, California, United States

Location

Phenomix Investigational Site 103

Long Beach, California, United States

Location

Phenomix Investigational Site 106

Los Angeles, California, United States

Location

Phenomix Investigational Site 143

Coral Gables, Florida, United States

Location

Phenomix Investigational Site 142

Hialeah, Florida, United States

Location

Phenomix Investigational Site 119

Jacksonville, Florida, United States

Location

Phenomix Investigational Site 133

Kissimmee, Florida, United States

Location

Phenomix Investigational Site 141

Dunwoody, Georgia, United States

Location

Phenomix Investigational Site 101

Honolulu, Hawaii, United States

Location

Phenomix Investigational Site 135

Chicago, Illinois, United States

Location

Phenomix Investigational Site 124

Indianapolis, Indiana, United States

Location

Phenomix Investigational Site 127

Indianapolis, Indiana, United States

Location

Phenomix Investigational Site 136

Brockton, Massachusetts, United States

Location

Phenomix Investigational Site 125

Kalamazoo, Michigan, United States

Location

Phenomix Investigational Site 138

Biloxi, Mississippi, United States

Location

Phenomix Investigational Site 122

Las Vegas, Nevada, United States

Location

Phenomix Investigational Site 140

Las Vegas, Nevada, United States

Location

Phenomix Investigational Site 131

Brick, New Jersey, United States

Location

Phenomix Investigational Site 110

Trenton, New Jersey, United States

Location

Phenomix Investigational Site 116

Albuquerque, New Mexico, United States

Location

Phenomix Investigational Site 107

Winston-Salem, North Carolina, United States

Location

Phenomix Investigational Site 130

Cincinnati, Ohio, United States

Location

Phenomix Investigational Site 118

Cuyahoga Falls, Ohio, United States

Location

Phenomix Investigational Site 112

Greenville, South Carolina, United States

Location

Phenomix Investigational Site 102

Dallas, Texas, United States

Location

Phenomix Investigational Site 139

Dallas, Texas, United States

Location

Phenomix Investigational Site 126

El Paso, Texas, United States

Location

Phenomix Investigational Site 104

San Antonio, Texas, United States

Location

Phenomix Investigational Site 100

Kenosha, Wisconsin, United States

Location

Phenomix Investigational Site 401

Buenos Aires, Argentina

Location

Phenomix Investigational Site 402

Buenos Aires, Argentina

Location

Phenomix Investigational Site 404

Buenos Aires, Argentina

Location

Phenomix Investigational Site 405

Buenos Aires, Argentina

Location

Phenomix Investigational Site 406

Buenos Aires, Argentina

Location

Phenomix Investigational Site 407

Buenos Aires, Argentina

Location

Phenomix Investigational Site 408

Buenos Aires, Argentina

Location

Phenomix Investigational Site 409

Buenos Aires, Argentina

Location

Phenomix Investigational Site 411

Buenos Aires, Argentina

Location

Phenomix Investigational Site 403

Corrientes, Argentina

Location

Phenomix Investigational Site 410

Mendoza, Argentina

Location

Phenomix Investigational Site 400

Rosario, Argentina

Location

Phenomix Investigational Site 502

Santiago, Chile

Location

Phenomix Investigational Site 504

Santiago, Chile

Location

Phenomix Investigational Site 505

Santiago, Chile

Location

Phenomix Investigational Site 500

Temuco, Chile

Location

Phenomix Investigational Site 501

Temuco, Chile

Location

Phenomix Investigational Site 209

Chodov, Czechia

Location

Phenomix Investigational Site 205

Havířov-Město, Czechia

Location

Phenomix Investigational Site 204

Liberec, Czechia

Location

Phenomix Investigational Site 202

Olomouc, Czechia

Location

Phenomix Investigational Site 206

Ostrava-Kunčice, Czechia

Location

Phenomix Investigational Site 208

Prague, Czechia

Location

Phenomix Investigational Site 203

Prostějov, Czechia

Location

Phenomix Investigational Site 207

Uničov, Czechia

Location

Phenomix Investigational Site 201

Valašské Klobouky, Czechia

Location

Phenomix Investigational Site 703

Hyderabad, Andhara Pradesh, India

Location

Phenomix Investigational Site 704

Visakhapatanam, Andhra Pradesh, India

Location

Phenomix Investigational Site 709

Gopālapuram, Chennai, India

Location

Phenomix Investigational Site 707

Shāstrinagar, Jaipur, India

Location

Phenomix Investigational Site 701

Bangalore, Karnataka, India

Location

Phenomix Investigational Site 702

Bangalore, Karnataka, India

Location

Phenomix Investigational Site 705

Trivandrum, Kerala, India

Location

Phenomix Investigational Site 706

Indore, Madhya Pradesh, India

Location

Phenomix Investigational Site 711

Mumbai, Maharashtra, India

Location

Phenomix Investigational Site 700

Nashik, Maharashtra, India

Location

Phenomix Investigational Site 710

Navi Mumbai, Maharashtra, India

Location

Phenomix Investigational Site 708

Chennai, India

Location

Phenomix Investigational Site 607

Arequipa, Peru

Location

Phenomix Investigational Site 601

Ica, Peru

Location

Phenomix Investigational Site 600

Lima, Peru

Location

Phenomix Investigational Site 603

Lima, Peru

Location

Phenomix Investigational Site 604

Lima, Peru

Location

Phenomix Investigational Site 608

Lima, Peru

Location

Phenomix Investigational Site 610

Lima, Peru

Location

Phenomix Investigational Site 605

Lima Cercado, Peru

Location

Phenomix Investigational Site 606

Piura, Peru

Location

Phenomix Investigational Site 602

Trujillo, Peru

Location

Phenomix Investigational Site 609

Wanchaq Cusco, Peru

Location

Phenomix Investigational Site 300

Gdansk, Poland

Location

Phenomix Investigational Site 301

Gdansk, Poland

Location

Phenomix Investigational Site 303

Katowice, Poland

Location

Phenomix Investigational Site 312

Katowice, Poland

Location

Phenomix Investigational Site 309

Krakow, Poland

Location

Phenomix Investigational Site 313

Krakow, Poland

Location

Phenomix Investigational Site 308

Lublin, Poland

Location

Phenomix Investigational Site 310

Poznan, Poland

Location

Phenomix Investigational Site 306

Puławy, Poland

Location

Phenomix Investigational Site 304

Szczecin, Poland

Location

Phenomix Investigational Site 305

Warsaw, Poland

Location

Phenomix Investigational Site 307

Warsaw, Poland

Location

Phenomix Investigational Site 311

Warsaw, Poland

Location

Phenomix Investigational Site 302

Wroclaw, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dutogliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

AR (12); PL (14); PE (11); CZ (9); US (34); IN (12); CL (5)