Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01778049

First received: January 24, 2013

Last updated: March 4, 2016

Last verified: March 2016

History of Changes

Results First Received: March 4, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: BI 10773 Drug: BI 10773 Placebo Drug: BI 10773 / BI 1356 Drug: BI 10773 / BI 1356 Placebo

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
Subjects randomised to 16 week(wk) open-label (OL) treatment with either empagliflozin (empa) 25 or empa 10 treatment, thereafter subjects entered to 1 wk open label placebo (Plc) add-on period in order to complete further eligibility evaluations before being randomised into 1 of the 24 wk double-blind treatment groups.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a randomised, double-blind, multi-national, parallel group trial. In this trial the treatment effects of linagliptin (lina) 5 compared with Plc were analysed as add-on to either empa 25 or empa 10. All trial treatments were administered in addition to metformin background treatment.

Reporting Groups

	Description
Empa 10 mg OL	Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
Empa 25 mg OL	Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
Lina5 (E10)	Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
Plc (E10)	Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
Lina5 (E25)	Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
Plc (E25)	Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.

Participant Flow for 2 periods

Period 1: Open Label Treatment Period

	Empa 10 mg OL	Empa 25 mg OL
STARTED	354	355
COMPLETED	256	226
NOT COMPLETED	98	129
Adverse Event	5	15
Lack of Efficacy	1	1
Protocol Violation	5	5
Lost to Follow-up	4	3
Withdrawal by Subject	4	10
Not treated	2	1
Other reason not defined above	77	94

Period 2: Double Blind Treatment Period

	Lina5 (E10)	Plc (E10)	Lina5 (E25)	Plc (E25)
STARTED	126	130	114	112
COMPLETED	111	118	102	105
NOT COMPLETED	15	12	12	7
Adverse Event	4	5	3	2
Lack of Efficacy	0	0	0	1
Protocol Violation	2	0	0	0
Lost to Follow-up	4	1	5	2
Withdrawal by Subject	1	2	0	1
Not treated	0	2	2	0
Other reason not defined above	4	2	2	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.
The open-label treated set (OLTS) was used for the open label treatment period. This analysis set consisted of all patients who received at least 1 dose of open-label treatment during the trial.

Reporting Groups

	Description
Empa 10 mg OL	Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
Empa 25 mg OL	Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
Total	Total of all reporting groups

Baseline Measures

	Empa 10 mg OL	Empa 25 mg OL	Total
Overall Participants Analyzed [Units: Participants]	352	354	706

Age [Units: Years] Mean (Standard Deviation)	57.0 (9.6)	56.7 (9.9)	56.8 (9.8)

Gender [Units: Participants]
Female	145	161	306
Male	207	193	400

Outcome Measures

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1. Primary:

Change From Baseline of HbA1c After 24 Weeks of Treatment. [ Time Frame: Baseline and 24 weeks ]

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2. Secondary:

Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks. [ Time Frame: Baseline and 24 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: Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.

Results Point of Contact:

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

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01778049 History of Changes
Other Study ID Numbers:	1275.10 2012-002271-34 ( EudraCT Number: EudraCT )
Study First Received:	January 24, 2013
Results First Received:	March 4, 2016
Last Updated:	March 4, 2016

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