Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00881530

First received: April 14, 2009

Last updated: September 27, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 14, 2009

Last Updated Date

September 27, 2012

Start Date ^ICMJE

March 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary endpoints are all safety relevant parameters: [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
incidence of adverse events; incidence of hypoglycemic events; use of rescue therapy; change from baseline in vital signs, body weight, waist circumference, lipid parameters to week 78; significant changes from baseline in clinical laboratory [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00881530 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in HbA1c from baseline (over time and after 78 weeks) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
percentage of patients treated to target HbA1c < 7.0 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Change in fasting plasma glucose (over time and after 78 weeks) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
occurence of an additional treat to target response, defined as an HbA1c after 78 weeks of <6.5% [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
occurence of a relative efficacy response (HbA1c lowered by >=0.5% after 78 weeks of treatment) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: BI 10773
BI 10773 high dose once daily
Drug: Metformin
open label comparator
Drug: BI 10773
BI 10773 low dose once daily
Drug: Sitagliptin
open label comparator

Study Arm (s)

Active Comparator: Sitagliptin
100 mg

Intervention: Drug: Sitagliptin
Active Comparator: Metformin
2000 mg

Intervention: Drug: Metformin
Experimental: BI 10773 X mg
lower dose

Intervention: Drug: BI 10773
Experimental: BI 10773 Y mg
higher dose

Intervention: Drug: BI 10773

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

660

Completion Date

Not Provided

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 nursing or pregnant or not practicing acceptable methods of birth control
drug or alcohol abuse

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Norway, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT00881530

Other Study ID Numbers ^ICMJE

1245.24, 2008-007938-21

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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