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

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

  Participant Flow

  Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

  Hide Baseline Characteristics

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
Overall Participants Analyzed; [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

  Show All Outcome Measures

1. Primary:

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

  Show Outcome Measure 1

2. Secondary:

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

  Show Outcome Measure 2

3. Secondary:

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

  Show Outcome Measure 3

4. Secondary:

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

  Show Outcome Measure 4

  Serious Adverse Events

  Show Serious Adverse Events

  Other Adverse Events

  Show Other Adverse Events

  Limitations and Caveats

  Hide Limitations and Caveats

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
No text entered.

  More Information

  Hide More Information

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 )
First Submitted:	February 28, 2011
First Posted:	March 1, 2011
Results First Submitted:	May 16, 2014
Results First Posted:	June 17, 2014
Last Update Posted:	June 17, 2014