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

This study has been terminated.
Sponsor:
Collaborator:
Phenomix
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00970424
First received: September 1, 2009
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type II
Drug: Placebo
Drug: Dutogliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: August 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00970424     History of Changes
Other Study ID Numbers: DUT-MD-304
Study First Received: September 1, 2009
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014