Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01215097
First received: September 28, 2010
Last updated: December 5, 2013
Last verified: June 2013
Results First Received: April 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Linagliptin
Drug: placebo

  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 614 patients were screened in 19 centres in China, Malaysia,and Philippines.A total of 306 patients were randomised in a 1:2 ratio to receive either placebo (101 patients) or linagliptin 5 mg (205 patients) in addition to 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
Placebo Placebo
Linagliptin 5mg Linagliptin 5mg, once daily tablets, oral

Participant Flow:   Overall Study
    Placebo     Linagliptin 5mg  
STARTED     100 [1]   205 [2]
COMPLETED     88     191  
NOT COMPLETED     12     14  
Adverse Event                 1                 3  
Protocol Violation                 0                 2  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 6                 3  
Lack of Efficacy                 0                 3  
patient's refusal to come                 2                 2  
patient's private reason                 1                 1  
[1] Patients who are randomised and treated with placebo. 1 patient was not treated then not included.
[2] Patients who are randomised and treated with linagliptin.



  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
Placebo Placebo
Linagliptin 5mg Linagliptin 5mg, once daily tablets, oral
Total Total of all reporting groups

Baseline Measures
    Placebo     Linagliptin 5mg     Total  
Number of Participants  
[units: participants]
  100     205     305  
Age  
[units: years]
Mean ± Standard Deviation
  56.5  ± 8.7     55.1  ± 10.7     55.5  ± 10.1  
Gender  
[units: Number¬†of¬†participants]
     
Female     50     103     153  
Male     50     102     152  
BMI [1]
[units: kg/m^2]
Mean ± Standard Deviation
  25.8  ± 4.0     25.5  ± 3.9     25.6  ± 4.0  
Baseline HbA1c [2]
[units: %]
Mean ± Standard Deviation
  8.00  ± 0.80     7.99  ± 0.83     7.99  ± 0.82  
Baseline fasting plasma glucose [3]
[units: mg/dL]
Mean ± Standard Deviation
  157.7  ± 36.8     160.5  ± 40.1     159.6  ± 39.0  
[1] Baseline body mass index (BMI)
[2] Baseline HbA1c
[3] Baseline fasting plasma glucose



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1c Change From Baseline at Week 24   [ Time Frame: Baseline and at week 24 ]

2.  Secondary:   HbA1c Change From Baseline at Week 6   [ Time Frame: Baseline and at week 6 ]

3.  Secondary:   HbA1c Change From Baseline at Week 12   [ Time Frame: Baseline and at week 12 ]

4.  Secondary:   HbA1c Change From Baseline at Week 18   [ Time Frame: Baseline and at week 18 ]

5.  Secondary:   HbA1c Change From Baseline at Week 24(Chinese Only)   [ Time Frame: Baseline and at 24 weeks ]

6.  Secondary:   FPG Change From Baseline at Week 24   [ Time Frame: Baseline and at week 24 ]

7.  Secondary:   FPG Change From Baseline at Week 6   [ Time Frame: Baseline and at week 6 ]

8.  Secondary:   FPG Change From Baseline at Week 12   [ Time Frame: Baseline and at week 12 ]

9.  Secondary:   FPG Change From Baseline at Week 18   [ Time Frame: Baseline and at week 18 ]

10.  Secondary:   Number of Patients With HbA1c < 7.0%   [ Time Frame: baseline and at week 24 ]

11.  Secondary:   Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.   [ Time Frame: baseline and at week 24 ]

12.  Secondary:   Number of Patients With HbA1c < 6.5%   [ Time Frame: baseline and at week 24 ]

13.  Secondary:   Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.   [ Time Frame: baseline and at week 24 ]

14.  Secondary:   Number With HbA1c at Least Lowering 0.5%   [ Time Frame: baseline and at week 24 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


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: NCT01215097     History of Changes
Other Study ID Numbers: 1218.65
Study First Received: September 28, 2010
Results First Received: April 16, 2013
Last Updated: December 5, 2013
Health Authority: China: Food and Drug Administration
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs