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

Sponsor:	Forest Laboratories
Collaborator:	Phenomix
Information provided by (Responsible Party):	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 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Glimepiride

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 24, 2012