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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00998686
Recruitment Status : Terminated
First Posted : October 20, 2009
Last Update Posted : August 11, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: dutogliptin Drug: sitagliptin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: dutogliptin/PHX1149T Drug: dutogliptin
400 mg
Active Comparator: sitagliptin Drug: sitagliptin
100 mg


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose [ Time Frame: 52 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 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