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

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: placebo; Drug: dutogliptin

• Registration Number: NCT00850239
• Lead Sponsor: Phenomix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-24
• Study Start: 2009-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• 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)

Exclusion Criteria

• Type 1 diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	placebo	Plabeco
1	dutogliptin	dutogliptin/PHX1149T

Primary Outcome Measures

Name	Time	Method
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.	26 weeks

Secondary Outcome Measures

Name	Time	Method
Demonstrate safety and tolerability of dutogliptin	26 weeks
• Demonstrate changes in fasting plasma glucose	26 weeks

Trial Locations

Locations (97)

Phenomix Investigational Site 112; 🇺🇸 Greenville, South Carolina, United States

Phenomix Investigational Site 406; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 401; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 400; 🇦🇷 Rosario, Argentina

Phenomix Investigational Site 405; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 115; 🇺🇸 Montgomery, Alabama, United States

Phenomix Investigational Site 208; 🇨🇿 Praha, Czech Republic

Phenomix Investigational Site 703; 🇮🇳 Hyderabad, Andhara Pradesh, India

Phenomix Investigational Site 119; 🇺🇸 Jacksonville, Florida, United States

Phenomix Investigational Site 138; 🇺🇸 Biloxi, Mississippi, United States

Phenomix Investigational Site 131; 🇺🇸 Brick, New Jersey, United States

Phenomix Investigational Site 410; 🇦🇷 Mendoza, Argentina

Phenomix Investigational Site 404; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 409; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 502; 🇨🇱 Santiago, Chile

Phenomix Investigational Site 505; 🇨🇱 Santiago, Chile

Phenomix Investigational Site 402; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 407; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 134; 🇺🇸 Escondido, California, United States

Phenomix Investigational Site 103; 🇺🇸 Long Beach, California, United States

Phenomix Investigational Site 123; 🇺🇸 Chico, California, United States

Phenomix Investigational Site 126; 🇺🇸 El Paso, Texas, United States

Phenomix Investigational Site 143; 🇺🇸 Coral Gables, Florida, United States

Phenomix Investigational Site 500; 🇨🇱 Temuco, Chile

Phenomix Investigational Site 205; 🇨🇿 Havířov-Město, Czech Republic

Phenomix Investigational Site 403; 🇦🇷 Corrientes, Argentina

Phenomix Investigational Site 110; 🇺🇸 Trenton, New Jersey, United States

Phenomix Investigational Site 711; 🇮🇳 Mumbai, Maharastra, India

Phenomix Investigational Site 304; 🇵🇱 Szczecin, Poland

Phenomix Investigational Site 602; 🇵🇪 Trujillo, Peru

Phenomix Investigational Site 301; 🇵🇱 Gdańsk, Poland

Phenomix Investigational Site 133; 🇺🇸 Kissimmee, Florida, United States

Phenomix Investigational Site 105; 🇺🇸 Anaheim, California, United States

Phenomix Investigational Site 142; 🇺🇸 Hialeah, Florida, United States

Phenomix Investigational Site 121; 🇺🇸 Tempe, Arizona, United States

Phenomix Investigational Site 130; 🇺🇸 Cincinnati, Ohio, United States

Phenomix Investigational Site 139; 🇺🇸 Dallas, Texas, United States

Phenomix Investigational Site 137; 🇺🇸 Tempe, Arizona, United States

Phenomix Investigational Site 106; 🇺🇸 Los Angeles, California, United States

Phenomix Investigational Site 141; 🇺🇸 Dunwoody, Georgia, United States

Phenomix Investigational Site 124; 🇺🇸 Indianapolis, Indiana, United States

Phenomix Investigational Site 102; 🇺🇸 Dallas, Texas, United States

Phenomix Investigational Site 100; 🇺🇸 Kenosha, Wisconsin, United States

Phenomix Investigational Site 135; 🇺🇸 Chicago, Illinois, United States

Phenomix Investigational Site 127; 🇺🇸 Indianapolis, Indiana, United States

Phenomix Investigational Site 122; 🇺🇸 Las Vegas, Nevada, United States

Phenomix Investigational Site 140; 🇺🇸 Las Vegas, Nevada, United States

Phenomix Investigational Site 408; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 411; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 118; 🇺🇸 Cuyahoga Falls, Ohio, United States

Phenomix Investigational Site 125; 🇺🇸 Kalamazoo, Michigan, United States

Phenomix Investigational Site 104; 🇺🇸 San Antonio, Texas, United States

Phenomix Investigational Site 204; 🇨🇿 Liberec, Czech Republic

Phenomix Investigational Site 209; 🇨🇿 Chodov, Czech Republic

Phenomix Investigational Site 600; 🇵🇪 Lima, Peru

Phenomix Investigational Site 608; 🇵🇪 Lima, Peru

Phenomix Investigational Site 710; 🇮🇳 Navi Mumbai, Maharashtra, India

Phenomix Investigational Site 706; 🇮🇳 Indore, Madhya Pradesh, India

Phenomix Investigational Site 604; 🇵🇪 Lima, Peru

Phenomix Investigational Site 300; 🇵🇱 Gdańsk, Poland

Phenomix Investigational Site 312; 🇵🇱 Katowice, Poland

Phenomix Investigational Site 309; 🇵🇱 Kraków, Poland

Phenomix Investigational Site 310; 🇵🇱 Poznan, Poland

Phenomix Investigational Site 306; 🇵🇱 Puławy, Poland

Phenomix Investigational Site 308; 🇵🇱 Lublin, Poland

Phenomix Investigational Site 307; 🇵🇱 Warszawa, Poland

Phenomix Investigational Site 311; 🇵🇱 Warszawa, Poland

Phenomix Investigational Site 305; 🇵🇱 Warszawa, Poland

Phenomix Investigational Site 302; 🇵🇱 Wrocław, Poland

Phenomix Investigational Site 202; 🇨🇿 Olomouc, Czech Republic

Phenomix Investigational Site 206; 🇨🇿 Ostrava Kunčice, Czech Republic

Phenomix Investigational Site 201; 🇨🇿 Valašské Klobouky, Czech Republic

Phenomix Investigational Site 701; 🇮🇳 Bangalore, Karnataka, India

Phenomix Investigational Site 702; 🇮🇳 Bangalore, Karnataka, India

Phenomix Investigational Site 605; 🇵🇪 Cercado de Lima, Peru

Phenomix Investigational Site 603; 🇵🇪 Lima, Peru

Phenomix Investigational Site 700; 🇮🇳 Nashik, Maharashtra, India

Phenomix Investigational Site 501; 🇨🇱 Temuco, Chile

Phenomix Investigational Site 709; 🇮🇳 Gopalapuram, Chennai, India

Phenomix Investigational Site 707; 🇮🇳 Shastrinagar, Jaipur, India

Phenomix Investigational Site 607; 🇵🇪 Arequipa, Peru

Phenomix Investigational Site 601; 🇵🇪 Ica, Peru

Phenomix Investigational Site 606; 🇵🇪 Piura, Peru

Phenomix Investigational Site 207; 🇨🇿 Uničov, Czech Republic

Phenomix Investigational Site 609; 🇵🇪 Wanchaq Cusco, Peru

Phenomix Investigational Site 303; 🇵🇱 Katowice, Poland

Phenomix Investigational Site 313; 🇵🇱 Kraków, Poland

Phenomix Investigational Site 203; 🇨🇿 Prostějov, Czech Republic

Phenomix Investigational Site 708; 🇮🇳 Chennai, India

Phenomix Investigational Site 704; 🇮🇳 Visakhapatanam, Andhra Pradesh, India

Phenomix Investigational Site 504; 🇨🇱 Santiago, Chile

Phenomix Investigational Site 705; 🇮🇳 Trivandrum, Kerala, India

Phenomix Investigational Site 610; 🇵🇪 Lima, Peru

Phenomix Investigational Site 101; 🇺🇸 Honolulu, Hawaii, United States

Phenomix Investigational Site 116; 🇺🇸 Albuquerque, New Mexico, United States

Phenomix Investigational Site 107; 🇺🇸 Winston-Salem, North Carolina, United States

Phenomix Investigational Site 136; 🇺🇸 Brockton, Massachusetts, United States