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Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01422876
First received: August 23, 2011
Last updated: April 1, 2015
Last verified: March 2015
History of Changes
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: high dose FDC
Drug: BI 10773 high dose
Drug: high dose FDC placebo
Drug: low dose FDC placebo
Drug: high dose BI 10773 placebo
Drug: low dose FDC
Drug: BI 10773 low dose
Drug: linagliptin
Drug: linagliptin placebo
Drug: BI 10773 low dose placebo
Drug: low dose BI 10773 placebo

  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
Of the 1405 patients enrolled and randomized the data for 42 randomized patients were excluded from all analyses due to serious non-compliance. Therefore, 1363 patients were included in the analyses.

Reporting Groups
  Description
Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral
Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.

Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
Metformin Background: Empagliflozin 25 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
Metformin Background: Empagliflozin 10 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
Metformin Background: Linagliptin 5 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.

Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
Treatment Naive: Empagliflozin 25 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
Treatment Naive: Empagliflozin 10 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
Treatment Naive: Linagliptin 5 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral

Participant Flow for 2 periods

 Period 1:   Week 24
    Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg   Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg   Metformin Background: Empagliflozin 25 mg   Metformin Background: Empagliflozin 10 mg   Metformin Background: Linagliptin 5 mg   Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg   Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg   Treatment Naive: Empagliflozin 25 mg   Treatment Naive: Empagliflozin 10 mg   Treatment Naive: Linagliptin 5 mg
STARTED   137   136   141   140   132   137   136   135   134   135 
COMPLETED   131   133   136   132   125   131   130   128   128   125 
NOT COMPLETED   6   3   5   8   7   6   6   7   6   10 
Lost to Follow-up                1                1                2                4                2                0                1                3                3                4 
Consent withdrawn                5                1                3                4                5                6                5                4                3                6 
Death                0                1                0                0                0                0                0                0                0                0 

Period 2:   Week 52
    Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg   Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg   Metformin Background: Empagliflozin 25 mg   Metformin Background: Empagliflozin 10 mg   Metformin Background: Linagliptin 5 mg   Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg   Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg   Treatment Naive: Empagliflozin 25 mg   Treatment Naive: Empagliflozin 10 mg   Treatment Naive: Linagliptin 5 mg
STARTED   137   136   141   140   132   137   136   135   134   135 
COMPLETED   125   126   128   122   117   120   120   112   113   118 
NOT COMPLETED   12   10   13   18   15   17   16   23   21   17 
Lost to Follow-up                3                5                7                5                8                5                5                8                7                8 
Consent withdrawn                9                4                6                12                7                12                10                12                13                9 
Death                0                1                0                1                0                0                1                3                1                0 



  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.
FAS

Reporting Groups
  Description
Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
Metformin Background: Empagliflozin 25 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
Metformin Background: Empagliflozin 10 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
Metformin Background: Linagliptin 5 mg

Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
Treatment Naive: Empagliflozin 25 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
Treatment Naive: Empagliflozin 10 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
Treatment Naive: Linagliptin 5 mg

Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.

Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
Total Total of all reporting groups

Baseline Measures
   Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg   Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg   Metformin Background: Empagliflozin 25 mg   Metformin Background: Empagliflozin 10 mg   Metformin Background: Linagliptin 5 mg   Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg   Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg   Treatment Naive: Empagliflozin 25 mg   Treatment Naive: Empagliflozin 10 mg   Treatment Naive: Linagliptin 5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 134   135   140   137   128   134   135   133   132   133   1341 
Age 
[Units: Years]
Mean (Standard Deviation) 		 57.1  (10.2)   56.2  (10.3)   55.5  (10.0)   56.1  (10.5)   56.2  (10.0)   54.2  (10.0)   55.2  (9.8)   56.0  (9.3)   53.9  (10.5)   53.8  (11.5)   55.4  (10.2) 
Gender 
[Units: Participants]
 		                     
Female   62   52   75   59   64   64   62   56   68   58   620 
Male   72   83   65   78   64   70   73   77   64   75   721 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients   [ Time Frame: Baseline and 24 weeks ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients   [ Time Frame: Baseline and 24 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients   [ Time Frame: Baseline and 24 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients   [ Time Frame: Baseline and 24 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Body Weight for Metformin Background Patients   [ Time Frame: Baseline and 24 Weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Body Weight for Treatment Naive Patients   [ Time Frame: Baseline and 24 Weeks ]
  Show Outcome Measure 6

7.  Secondary:   Occurrence of Treat to Target Efficacy Response for Metformin Background Patients   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 7

8.  Secondary:   Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 8


  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:
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


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


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01422876     History of Changes
Other Study ID Numbers: 1275.1
2011-000383-10 ( EudraCT Number: EudraCT )
Study First Received: August 23, 2011
Results First Received: January 15, 2015
Last Updated: April 1, 2015