Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
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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: NCT00309608 |
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Recruitment Status :
Completed
First Posted : April 3, 2006
Results First Posted : June 15, 2011
Last Update Posted : July 8, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Type 2 |
| Interventions |
Drug: Linagliptin Drug: Placebo Drug: Glimepiride |
| Enrollment | 333 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Placebo | Linagliptin 1 mg | Linagliptin 5 mg | Linagliptin 10 mg | Glimepiride |
|---|---|---|---|---|---|
 Arm/Group Description |
Patients randomized to receive treatment with matching placebo | Patients randomized to receive treatment with Linagliptin 1 mg | Patients randomized to receive treatment with Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 10 mg | Patients randomized to receive treatment with Glimepiride |
| Period Title: Overall Study | |||||
| Started | 71 | 65 | 66 | 66 | 65 |
| Completed | 57 | 52 | 56 | 60 | 61 |
| Not Completed | 14 | 13 | 10 | 6 | 4 |
| Reason Not Completed | |||||
| Adverse Event | 1 | 5 | 3 | 2 | 3 |
| Protocol Violation | 2 | 0 | 0 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 2 | 0 | 1 |
| Withdrawal by Subject | 1 | 4 | 2 | 0 | 0 |
| Other incl. Lack of efficacy | 10 | 4 | 3 | 4 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | Linagliptin 1 mg | Linagliptin 5 mg | Linagliptin 10 mg | Glimepiride | Total | |
|---|---|---|---|---|---|---|---|
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Arm/Group Description |
Patients randomized to receive treatment with matching placebo | Patients randomized to receive treatment with Linagliptin 1 mg | Patients randomized to receive treatment with Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 10 mg | Patients randomized to receive treatment with Glimepiride | Total of all reporting groups | |
| Overall Number of Baseline Participants | 71 | 65 | 66 | 66 | 65 | 333 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 71 participants | 65 participants | 66 participants | 66 participants | 65 participants | 333 participants | |
| 60.1 (8.1) | 59.2 (8.4) | 59.6 (9.8) | 61.8 (8.8) | 59.4 (9.9) | 60.0 (9.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 71 participants | 65 participants | 66 participants | 66 participants | 65 participants | 333 participants | |
| Female |
27 38.0%
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29 44.6%
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29 43.9%
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31 47.0%
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24 36.9%
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140 42.0%
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| Male |
44 62.0%
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36 55.4%
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37 56.1%
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35 53.0%
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41 63.1%
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193 58.0%
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Body Mass Index (BMI) continuous
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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| Number Analyzed | 71 participants | 65 participants | 66 participants | 66 participants | 65 participants | 333 participants | |
| 32.2 (4.2) | 32.3 (4.3) | 31.7 (4.5) | 31.7 (4.5) | 31.5 (4.2) | 31.9 (4.3) | ||
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Glycosylated Hemoglobin A1 (HbA1C) continuous
Mean (Standard Deviation) Unit of measure: Percent |
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| Number Analyzed | 71 participants | 65 participants | 66 participants | 66 participants | 65 participants | 333 participants | |
| 8.37 (0.74) | 8.24 (0.74) | 8.46 (0.85) | 8.35 (0.73) | 8.22 (0.70) | 8.33 (0.75) | ||
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Fasting plasma glucose (FPG) continuous
Mean (Standard Deviation) Unit of measure: mg/dL |
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| Number Analyzed | 71 participants | 65 participants | 66 participants | 66 participants | 65 participants | 333 participants | |
| 185.5 (38.8) | 182.3 (42.0) | 189.3 (42.4) | 188.7 (42.4) | 179.9 (40.4) | 185.1 (41.0) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
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 |
| EMail: | clintriage.rdg@boehringer-ingelheim.com |
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00309608 |
| Other Study ID Numbers: |
1218.6 2005-004597-24 ( EudraCT Number: EudraCT ) |
| First Submitted: | March 31, 2006 |
| First Posted: | April 3, 2006 |
| Results First Submitted: | May 13, 2011 |
| Results First Posted: | June 15, 2011 |
| Last Update Posted: | July 8, 2014 |