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

This study has been terminated.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00998686
First received: October 16, 2009
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: dutogliptin
Drug: sitagliptin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Phenomix:

Primary Outcome Measures:
  • To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dutogliptin/PHX1149T Drug: dutogliptin
400 mg
Active Comparator: sitagliptin Drug: sitagliptin
100 mg

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998686

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

No publications provided

Responsible Party: Michael Huang, MD, Phenomix
ClinicalTrials.gov Identifier: NCT00998686     History of Changes
Other Study ID Numbers: PHX1149-PROT402
Study First Received: October 16, 2009
Last Updated: August 10, 2010
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Romania: Ministry of Public Health
Romania: National Medicines Agency
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Peru: Ethics Committee
Peru: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Chile: Instituto de Salud Pública de Chile
China: Ethics Committee

Keywords provided by Phenomix:
diabetes
DPP4 inhibitor
dutogliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014