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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00998686
• Other study ID #: PHX1149-PROT402
• Status: Terminated
• Phase: Phase 3
• First received: October 16, 2009
• Last updated: August 10, 2010
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2010
• Source: Phenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlCzech Republic: Ethics CommitteeRomania: Ministry of Public HealthRomania: National Medicines AgencyPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsIndia: Drugs Controller General of IndiaPeru: Ethics CommitteePeru: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Human Research Bioethics CommitteeChile: Instituto de Salud Pública de ChileChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 650
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Completion of all required visits of a qualifying Phase 3 core protocol

• Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

Exclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• dutogliptin
400 mg
• sitagliptin
100 mg

Locations

Country	Name	City	State
Argentina	Phenomix Investigational Site 402	Buenos Aires
Argentina	Phenomix Investigational Site 408	Buenos Aires
Argentina	Phenomix Investigational Site 410	Mendoza
Czech Republic	Phenomix Investigational Site 208	Praha 10
Czech Republic	Phenomix Investigational Site 209	Praha 4 Chodov
Czech Republic	Phenomix Investigational Site 207	Unicov
India	Phenomix Investigational Site 701	Bangalore	Karnataka
India	Phenomix Investigational Site 706	Indore	Madhya Pradesh
India	Phenomix Investigational Site 711	Mumbai	Maharashtra
India	Phenomix Investigational Site 707	Shastrinagar	Jaipur
India	Phenomix Investigational Site 705	Trivandrum	Kerala
Peru	Phenomix Investigational Site 607	Arequipa
Peru	Phenomix Investigational Site 601	Ica
Peru	Phenomix Investigational Site 604	Lima
Peru	Phenomix Investigational Site 610	Lima
Poland	Phenomix Investigational Site 300	Gdansk
Poland	Phenomix Investigational Site 309	Karkow
Poland	Phenomix Investigational Site 303	Katowice
Poland	Phenomix Investigational Site 306	Pulawy
Poland	Phenomix Investigational Site 305	Warszawa
Poland	Phenomix Investigational Site 302	Wroclaw
United States	Phenomix Investigational Site 116	Albuquerque	New Mexico
United States	Phenomix Investigational Site 105	Anaheim	California
United States	Phenomix Investigational Site 138	Biloxi	Mississippi
United States	Phenomix Investigational Site 136	Brockton	Massachusetts
United States	Phenomix Investigational Site 135	Chicago	Illinois
United States	Phenomix Investigational Site 143	Coral Gables	Florida
United States	Phenomix Investigational Site 102	Dallas	Texas
United States	Phenomix Investigational Site 112	Greenville	South Carolina
United States	Phenomix Investigational Site 142	Hialeah	Florida
United States	Phenomix Investigational Site 101	Honolulu	Hawaii
United States	Phenomix Investigational Site 124	Indianapolis	Indiana
United States	Phenomix Investigational Site 100	Kenosha	Wisconsin
United States	Phenomix Investigational Site 133	Kissimmee	Florida
United States	Phenomix Investigational Site 122	Las Vegas	Nevada
United States	Phenomix Investigational Site 140	Las Vegas	Nevada
United States	Phenomix Investigational Site 103	Long Beach	California
United States	Phenomix Investigational Site 106	Los Angeles	California
United States	Phenomix Investigational Site 105	Montgomery	Alabama
United States	Phenomix Investigational Site 104	San Antonio	Texas
United States	Phenomix Investigational Site 121	Tempe	Arizona
United States	Phenomix Investigational Site 137	Tempe	Arizona
United States	Phenomix Investigational Site 110	Trenton	New Jersey
United States	Phenomix Investigational Site 107	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Phenomix	Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Czech Republic,  India,  Peru,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG		52 weeks	Yes
Secondary	To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose		52 weeks	No