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Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

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: NCT00970424
Recruitment Status : Terminated
First Posted : September 2, 2009
Last Update Posted : September 21, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: Placebo Drug: Dutogliptin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone
Study Start Date : August 2009
Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
placebo, oral tablet administered once daily on background of pioglitazone
Drug: Placebo
placebo, oral tablet administered once daily on background of pioglitazone
Experimental: 2
dutogliptin, oral tablet administered once daily on background of pioglitazone
Drug: Dutogliptin
dutogliptin, oral tablet administered once daily on background of pioglitazone


Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin A1c Level (HbA1c) [ Time Frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26) ]

Secondary Outcome Measures :
  1. Fasting Plasma Glucose Level (FPG) [ Time Frame: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26). ]

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:

  • Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
  • BMI 20 to 48 kg/m2, inclusive
  • HbA1c 7.0% - 10.0%, inclusive
  • Age 18 to 85 years, inclusive

Exclusion Criteria:

  • Currently taking more than one oral hypoglycemic agent
  • Type 1 diabetes mellitus
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): NCT00970424


  Show 118 Study Locations
Sponsors and Collaborators
Forest Laboratories
Phenomix
Investigators
Study Director: Kaity Posada, PharmD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00970424     History of Changes
Other Study ID Numbers: DUT-MD-304
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs