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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
  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
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 ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose [ Time Frame: 52 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 44 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories
  More Information

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

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
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
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 March 01, 2017