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Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

This study has been terminated.
Sponsor:
Collaborator:
Phenomix
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00947557
First received: July 23, 2009
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  Purpose

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.


Condition Intervention Phase
Diabetes Mellitus, Type II
 Drug: Dutogliptin
Drug: Placebo
 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 Glimepiride With or Without Metformin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Hemoglobin A1c (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), Visit 8 (Week 26). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting Plasma Glucose (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), Visit 8 (Week 26). ] [ Designated as safety issue: No ]

Enrollment: 677
Study Start Date: July 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dutogliptin
Dutogliptin
 Drug: Dutogliptin
Dutogliptin oral administration once daily on background of glimepiride with or without metformin
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo, oral administration once daily on background of glimepiride with or without metformin

  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 on 3 or more oral antidiabetic drugs or insulin.
  • Type 1 diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947557

  Show 147 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: NCT00947557     History of Changes
Other Study ID Numbers: DUT-MD-303
Study First Received: July 23, 2009
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration
Belarus: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Hungary: National Institute of Pharmacy
India: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Peru: Ministry of Health
Romania: National Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013