Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus; Type 2 Diabetes

• Registration Number: NCT00865592
• Lead Sponsor: Phenomix

Brief Summary

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Detailed Description

In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-19
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11
• Primary Completion: 2011-01
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
• Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

Exclusion Criteria

• Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
• Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To demonstrate safety and tolerability of dutogliptin	Two years

Secondary Outcome Measures

Name	Time	Method
To demonstrate maintenance or lowering of HbA1c	Two years
To demonstrate maintenance or lowering of fasting blood glucose	Two years

Trial Locations

Locations (40)

Phenomix Investigational Site 110; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 106; 🇦🇷 Caba, Argentina

Phenomix Investigational Site 112; 🇦🇷 Corrientes, Argentina

Phenomix Investigational Site 606; 🇵🇪 Lambayeque, Peru

Phenomix Investigational Site 600; 🇵🇪 Lima, Peru

Phenomix Investigational Site 602; 🇵🇪 Lima, Peru

Phenomix Investigational Site 703; 🇵🇭 Cebu City, Philippines

Phenomix Investigational Site 802; 🇷🇴 Brasov, Romania

Phenomix Investigational Site 807; 🇷🇴 Bucharest, Romania

Phenomix Investigational Site 804; 🇷🇴 Galati, Romania

Phenomix Investigational Site 801; 🇷🇴 Ploieşti, Romania

Phenomix Investigational Site 557; 🇺🇦 Kharkiv, Ukraine

Phenomix Investigational Site 403; 🇲🇾 Kuching, Sarawak, Malaysia

Phenomix Investigational Site 102; 🇦🇷 Paraná, Argentina

Phenomix Investigational Site 604; 🇵🇪 Arequipa, Peru

Phenomix Investigational Site 806; 🇷🇴 Brasov, Romania

Phenomix Investigational Site 800; 🇷🇴 Bucharest, Romania

Phenomix Investigational Site 601; 🇵🇪 Lima, Peru

Phenomix Investigational Site 609; 🇵🇪 Lima, Peru

Phenomix Investigational Site 803; 🇷🇴 Bucharest, Romania

Phenomix Investigational Site 805; 🇷🇴 Bucharest, Romania

Phenomix Investigational Site 808; 🇷🇴 Sibiu, Romania

Phenomix Investigational Site 551; 🇺🇦 Ivano-Frankivsk, Ukraine

Phenomix Investigational Site 564; 🇺🇦 Kharkiv, Ukraine

Phenomix Investigational Site 550; 🇺🇦 Kharkov, Ukraine

Phenomix Investigational Site 555; 🇺🇦 Kiev, Ukraine

Phenomix Investigational Site 556; 🇺🇦 Kiev, Ukraine

Phenomix Investigational Site 554; 🇺🇦 Kylv, Ukraine

Phenomix Investigational Site 553; 🇺🇦 Lviv, Ukraine

Phenomix Investigational Site 562; 🇺🇦 Kiev, Ukraine

Phenomix Investigational Site 565; 🇺🇦 Lutsk, Ukraine

Phenomix Investigational Site 560; 🇺🇦 Simferopol, Ukraine

Phenomix Investigational Site 559; 🇺🇦 Vinnitsa, Ukraine

Phenomix Investigational Site 552; 🇺🇦 Zaporzhzhia, Ukraine

Phenomix Investigational Site 404; 🇲🇾 Putrajaya, Malaysia

Phenomix Investigational Site 103; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 111; 🇦🇷 Buenos Aires, Argentina

Phenomix Investigational Site 563; 🇺🇦 Kiev, Ukraine

Phenomix Investigational Site 561; 🇺🇦 Poltava, Ukraine

Phenomix Investigational Site 663; 🇺🇸 Honolulu, Hawaii, United States