BI 10773 Phase II in T2D Patients, Open Label Extension - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00881530

Purpose

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 10773 Drug: Metformin Drug: Sitagliptin	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Primary endpoints are all safety relevant parameters: incidence of adverse events, incidence of hypoglycemic events, use of rescue therapy, change in vital signs, body weight, waist circumference, lipid parameters [ Time Frame: 78 weeks ]

Secondary Outcome Measures:

Change in HbA1c from baseline percentage of patients treated to target HbA1c < 7.0 Change in fasting plasma glucose [ Time Frame: 78 weeks ]

Estimated Enrollment:	688
Study Start Date:	March 2009
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients completing one of double blind phase II trials 1245.9 or 1245.10
informed consent

Exclusion Criteria:

patients meeting withdrawal criteria of preceding trial
significant hepatic impairment
significant renal impairment with creatinine clearance < 50 ml/min
contraindication to Metformin for all patients treated with Metformin
premenopausal women that are nursig or pregnant or not practicing acceptable methods of birth control
drug or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881530

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 77 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1245.24, EUDRACT 2008-007938-21
Study First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881530 History of Changes
Health Authority:	Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica; Austria: Federal Office for Safety in Health Care; Croatia: Agency for Medicinal Product and Medical Devices; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: Ethics Committee; Korea: Food and Drug Administration; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Norway: Norwegian Medicines Agency; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Taiwan: Department of Health; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009