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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
Results First Received: March 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   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   Lina5 (E10)   Plc (E10)   Lina5 (E25)   Plc (E25)
STARTED   354   355   0   0   0   0 
COMPLETED   256   226   0   0   0   0 
NOT COMPLETED   98   129   0   0   0   0 
Adverse Event                5                15                0                0                0                0 
Lack of Efficacy                1                1                0                0                0                0 
Protocol Violation                5                5                0                0                0                0 
Lost to Follow-up                4                3                0                0                0                0 
Withdrawal by Subject                4                10                0                0                0                0 
Not treated                2                1                0                0                0                0 
Other reason not defined above                77                94                0                0                0                0 

Period 2:   Double Blind Treatment Period
    Empa 10 mg OL   Empa 25 mg OL   Lina5 (E10)   Plc (E10)   Lina5 (E25)   Plc (E25)
STARTED   0   0   126   130   114   112 
COMPLETED   0   0   111   118   102   105 
NOT COMPLETED   0   0   15   12   12   7 
Adverse Event                0                0                4                5                3                2 
Lack of Efficacy                0                0                0                0                0                1 
Protocol Violation                0                0                2                0                0                0 
Lost to Follow-up                0                0                4                1                5                2 
Withdrawal by Subject                0                0                1                2                0                1 
Not treated                0                0                0                2                2                0 
Other reason not defined above                0                0                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
  Show All Outcome Measures

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

2.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Canadian Institutes of Health Research
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration