Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01422876 |
Recruitment Status
:
Completed
First Posted
: August 25, 2011
Results First Posted
: April 2, 2015
Last Update Posted
: April 2, 2015
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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; 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 |

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

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. |
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FAS |
Reporting Groups
Description | |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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] |
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Female | 62 | 52 | 75 | 59 | 64 | 64 | 62 | 56 | 68 | 58 | 620 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 72 | 83 | 65 | 78 | 64 | 70 | 73 | 77 | 64 | 75 | 721 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients [ Time Frame: Baseline and 24 weeks ] |
2. Primary: | Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients [ Time Frame: Baseline and 24 weeks ] |
3. Secondary: | Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ] |
4. Secondary: | Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients [ Time Frame: Baseline and 24 Weeks ] |
5. Secondary: | Change From Baseline in Body Weight for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ] |
6. Secondary: | Change From Baseline in Body Weight for Treatment Naive Patients [ Time Frame: Baseline and 24 Weeks ] |
7. Secondary: | Occurrence of Treat to Target Efficacy Response for Metformin Background Patients [ Time Frame: 24 Weeks ] |
8. Secondary: | Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients [ Time Frame: 24 Weeks ] |

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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No text entered. |

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:
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Results Point of Contact:
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 ) |
First Submitted: | August 23, 2011 |
First Posted: | August 25, 2011 |
Results First Submitted: | January 15, 2015 |
Results First Posted: | April 2, 2015 |
Last Update Posted: | April 2, 2015 |