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

This study is currently recruiting participants.

Verified by Forest Laboratories, December 2009

First Received: July 23, 2009 Last Updated: December 21, 2009 History of Changes

Sponsor:	Forest Laboratories
Collaborator:	Phenomix
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00947557

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Metformin Metformin hydrochloride

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 ]

Estimated Enrollment:	650
Study Start Date:	July 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dutogliptin: Active Comparator Dutogliptin	Drug: Dutogliptin Dutogliptin oral administration once daily on background of glimepiride with or without metformin
Placebo: Placebo Comparator 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

Contacts

Contact: Sandra Beaird, PhD

1-800-678-1605 ext 66297

info@forestpharm.com

Show 92 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 Research Institute, a subdisiary of Forest Laboratories, Inc. ( Harvey Schneier, MD / Executive Director )
Study ID Numbers:	DUT-MD-303
Study First Received:	July 23, 2009
Last Updated:	December 21, 2009
ClinicalTrials.gov Identifier:	NCT00947557 History of Changes
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:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010