Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone (REDWOOD403)

This study has been terminated.
Sponsor:
Collaborator:
Phenomix
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01089790
First received: March 17, 2010
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Dutogliptin
Drug: Sitagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: March 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dutogliptin
400 mg tablet, once daily
Other Name: PHX1149
Active Comparator: 2 Drug: Sitagliptin
100 mg capsule (each capsule contains two 50-mg tablets), once daily
Other Name: Januvia

  Eligibility

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have successfully completed all required visits of a qualifying Phase 3 core protocol
  • Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol

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: NCT01089790

  Show 149 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: NCT01089790     History of Changes
Other Study ID Numbers: DUT-MD-403
Study First Received: March 17, 2010
Last Updated: September 14, 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: Drugs Controller General of India
Lithuania: State Medicine Control Agency - Ministry of Health
Peru: Ministry of Health
Romania: State Institute for Drug Control
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
Pioglitazone
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014