Comprehensive Add on Study in Japan

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01204294
First received: September 16, 2010
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: December 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Linagliptin
Drug: Metformin

  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
A total of 618 patients were enrolled in the trial at 43 trial sites, and 37 patients were withdrawn from the trial because of screening failure. 581 patients were entered into the 2-week placebo run-in period, and 7 patients were withdrawn. 574 patients completed the 2-week placebo run-in period and took linagliptin 5 mg or metformin.

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

Reporting Groups
  Description
Bigu+Lina biguanide plus linagliptin
Glin+Lina glinide plus linagliptin
Glit+Lina glitazone plus linagliptin
SU+Lina sulfonylurea plus linagliptin
A-GI+Lina alpha-glucosidase inhibitor plus linagliptin
SU+Met sulfonylurea plus metformin
A-GI+Met alpha-glucosidase inhibitor plus metformin

Participant Flow:   Overall Study
    Bigu+Lina     Glin+Lina     Glit+Lina     SU+Lina     A-GI+Lina     SU+Met     A-GI+Met  
STARTED     82     66     74     143     85     63     61  
COMPLETED     79     58     69     132     83     58     59  
NOT COMPLETED     3     8     5     11     2     5     2  
Adverse Event                 2                 6                 0                 7                 1                 4                 0  
Protocol Violation                 1                 0                 2                 1                 0                 0                 0  
Withdrawal by Subject                 0                 2                 2                 1                 1                 1                 2  
Lack of Efficacy                 0                 0                 0                 2                 0                 0                 0  
Other (house moving)                 0                 0                 1                 0                 0                 0                 0  



  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.
No text entered.

Reporting Groups
  Description
Bigu+Lina biguanide plus linagliptin
Glin+Lina glinide plus linagliptin
Glit+Lina glitazone plus linagliptin
SU+Lina sulfonylurea plus linagliptin
A-GI+Lina alpha-glucosidase inhibitor plus linagliptin
SU+Met sulfonylurea plus metformin
A-GI+Met alpha-glucosidase inhibitor plus metformin
Total Total of all reporting groups

Baseline Measures
    Bigu+Lina     Glin+Lina     Glit+Lina     SU+Lina     A-GI+Lina     SU+Met     A-GI+Met     Total  
Number of Participants  
[units: participants]
  82     66     74     143     85     63     61     574  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  58.4  ± 9.9     62.6  ± 8.8     60.4  ± 9.4     61.8  ± 10.8     62.0  ± 10.4     61.2  ± 10.6     59.3  ± 10.3     60.9  ± 10.2  
Gender  
[units: Number¬†of¬†participants]
               
Female     33     18     16     38     30     19     19     173  
Male     49     48     58     105     55     44     42     401  



  Outcome Measures
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1.  Primary:   Incidence of Adverse Events (AEs)   [ Time Frame: The first drug administration through 7 days after the last drug administration, up to 382 days ]

2.  Secondary:   Glycosylated Haemoglobin A1c (HbA1c)   [ Time Frame: Baseline and 52 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01204294     History of Changes
Other Study ID Numbers: 1218.78
Study First Received: September 16, 2010
Results First Received: December 18, 2012
Last Updated: February 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare