Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
|
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: NCT00996658 |
|
Recruitment Status :
Completed
First Posted : October 16, 2009
Results First Posted : March 26, 2013
Last Update Posted : March 26, 2014
|
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Type 2 |
| Interventions |
Drug: Placebo Drug: Linagliptin |
| Enrollment | 278 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Placebo Tablet | Linagliptin 5 mg Tablet |
|---|---|---|
 Arm/Group Description |
Placebo matching linagliptin 5 mg tablet | Linagliptin 5 mg (milligrams) tablet given by mouth once daily |
| Period Title: Overall Study | ||
| Started | 92 | 186 |
| Completed | 76 | 165 |
| Not Completed | 16 | 21 |
| Reason Not Completed | ||
| Adverse Event | 2 | 5 |
| Protocol Violation | 0 | 1 |
| Lost to Follow-up | 2 | 5 |
| Non-compliance issues | 3 | 3 |
| Other | 9 | 7 |
Baseline Characteristics
| Arm/Group Title | Placebo Tablet | Linagliptin 5 mg Tablet | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
[Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 89 | 183 | 272 | |
|
Baseline Analysis Population Description |
Six participants (three participants per treatment) were excluded from all analyses due to serious site non-compliance. Thus, the total participants in Baseline Measures (272) is six less than total in Participant Flow (278).
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 89 participants | 183 participants | 272 participants | |
| 55.2 (8.4) | 53.1 (9.7) | 53.8 (9.3) | ||
|
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 89 participants | 183 participants | 272 participants |
| < 65 years | 79 | 162 | 241 | |
| 65 to 74 years | 8 | 20 | 28 | |
| >= 75 years | 2 | 1 | 3 | |
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 89 participants | 183 participants | 272 participants | |
| Female |
40 44.9%
|
100 54.6%
|
140 51.5%
|
|
| Male |
49 55.1%
|
83 45.4%
|
132 48.5%
|
|
|
Weight
Mean (Standard Deviation) Unit of measure: Kilograms |
||||
| Number Analyzed | 89 participants | 183 participants | 272 participants | |
| 74.4 (19.8) | 74.4 (20.4) | 74.4 (20.2) | ||
|
Weight categories
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 89 participants | 183 participants | 272 participants |
| <= 70 kilograms | 46 | 97 | 143 | |
| > 70 to 80 kilograms | 17 | 32 | 49 | |
| > 80 to 90 kilograms | 10 | 18 | 28 | |
| > 90 kilograms | 16 | 36 | 52 | |
|
Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kilograms per square meter |
||||
| Number Analyzed | 89 participants | 183 participants | 272 participants | |
| 28.1 (5.5) | 28.2 (5.2) | 28.2 (5.3) | ||
|
Body Mass Index (BMI) categories
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 89 participants | 183 participants | 272 participants |
| < 25 kilograms/square meter | 29 | 51 | 80 | |
| >= 25 and < 30 kilograms/square meter | 38 | 76 | 114 | |
| >= 30 kilograms/square meter | 22 | 56 | 78 | |
|
Height
Mean (Standard Deviation) Unit of measure: Centimeters |
||||
| Number Analyzed | 89 participants | 183 participants | 272 participants | |
| 162.0 (11.0) | 161.4 (11.4) | 161.6 (11.2) | ||
|
Waist circumference
Mean (Standard Deviation) Unit of measure: Centimeters |
||||
| Number Analyzed | 89 participants | 183 participants | 272 participants | |
| 97.7 (13.5) | 98.1 (13.1) | 98.0 (13.2) | ||
|
Smoking status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 89 participants | 183 participants | 272 participants |
| Never smoked | 75 | 151 | 226 | |
| Ex-smoker | 12 | 16 | 28 | |
| Currently smokes | 2 | 16 | 18 | |
|
Alcohol status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 89 participants | 183 participants | 272 participants |
| Non drinker | 79 | 156 | 235 | |
| Drinks - no interference with study | 10 | 27 | 37 | |
| Drinks - investigator opinion/interfere with study | 0 | 0 | 0 | |
Outcome Measures
Adverse Events
Limitations and Caveats
During the conduct of this trial, pioglitazone was removed from the market in France due to safety issues, and this resulted in premature termination of a number of French patients.
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00996658 |
| Other Study ID Numbers: |
1218.61 2009-013289-20 ( EudraCT Number: EudraCT ) |
| First Submitted: | October 15, 2009 |
| First Posted: | October 16, 2009 |
| Results First Submitted: | February 13, 2013 |
| Results First Posted: | March 26, 2013 |
| Last Update Posted: | March 26, 2014 |