Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01306214

First received: February 28, 2011

Last updated: May 16, 2014

Last verified: May 2014

History of Changes

Results First Received: May 16, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Diabetes Mellitus, Type 2 Obesity
Interventions:	Drug: Placebo Drug: BI 10773

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 10 mg	Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 25 mg	Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily

Participant Flow: Overall Study

	Placebo	Empagliflozin 10 mg	Empagliflozin 25 mg
STARTED	189	187	190
COMPLETED	161	159	168
NOT COMPLETED	28	28	22
Death	0	0	1
Lost to Follow-up	3	5	4
Withdrawal by Subject	24	22	16
Not treated	1	1	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): FAS included all randomised and treated patients who had a baseline HbA1c value.

Reporting Groups

	Description
Placebo	Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 10 mg	Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 25 mg	Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
Total	Total of all reporting groups

Baseline Measures

	Placebo	Empagliflozin 10 mg	Empagliflozin 25 mg	Total
Number of Participants [units: participants]	188	186	189	563
Age [units: years] Mean (Standard Deviation)	55.3 (10.1)	56.7 (8.7)	58.0 (9.4)	56.7 (9.5)
Gender [units: participants]
Female	113	89	105	307
Male	75	97	84	256

Outcome Measures

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1. Primary:

Change From Baseline in HbA1c After 18 Weeks of Treatment [ Time Frame: Baseline and 18 weeks ]

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2. Secondary:

Change From Baseline in Insulin Dose After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]

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3. Secondary:

Change From Baseline in Body Weight After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]

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4. Secondary:

Change From Baseline in HbA1c After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01306214 History of Changes
Other Study ID Numbers:	1245.49 2010-019968-37 ( EudraCT Number: EudraCT )
Study First Received:	February 28, 2011
Results First Received:	May 16, 2014
Last Updated:	May 16, 2014
Health Authority:	Belgium: Federal Agency for Medicinal and Health Products Bulgaria: Bulgarian Drug Agency Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Guatemala: Mexico: Federal Commission for Protection Against Health Risks Peru: Ministry of Health Russia: Pharmacological Committee, Ministry of Health Spain: Spanish Agency of Medicines Ukraine: State Pharmacological Center - Ministry of Health United States: Food and Drug Administration

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