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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 44 Study Locations
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 Publica 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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013