Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01708902
First received: October 16, 2012
Last updated: April 8, 2015
Last verified: April 2015
Results First Received: April 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: linagliptin2.5mg/metformin1000mg
Drug: linagliptin 5mg
Drug: Metformin 500mg
Drug: linagliptin2.5mg/metformin500mg
Drug: Metformin 1000mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After 2-weeks placebo run-in in the main group, 730 of 733 randomised patients were treated in a double-blind fashion for 24 weeks. In the additional parallel group (APG), all of 143 randomised patients with HbA1c >=11% were treated for 24 weeks (the first 12 weeks were double-blind). There was a 1-week follow-up period after treatment.

Reporting Groups
  Description
Main: Linagliptin 5mg QD Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
Main: Metformin 500mg BID Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
Main: Metformin 1000mg BID Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
Main: Linagliptin 2.5mg / Metformin 500mg BID Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
Main: Linagliptin 2.5mg / Metformin 1000mg BID Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
APG: Linagliptin 5mg QD

Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.

(Data up to week 12)

APG: Linagliptin 2.5mg / Metformin 1000mg BID

Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.

(Data up to week 12)


Participant Flow:   Overall Study
    Main: Linagliptin 5mg QD     Main: Metformin 500mg BID     Main: Metformin 1000mg BID     Main: Linagliptin 2.5mg / Metformin 500mg BID     Main: Linagliptin 2.5mg / Metformin 1000mg BID     APG: Linagliptin 5mg QD     APG: Linagliptin 2.5mg / Metformin 1000mg BID  
STARTED     147     145     144     147     147     71     72  
COMPLETED     130     137     127     137     131     64     65  
NOT COMPLETED     17     8     17     10     16     7     7  
Adverse Event                 3                 4                 9                 2                 7                 3                 5  
Lack of Efficacy                 3                 1                 0                 0                 0                 1                 0  
Non compliance with protocol                 0                 2                 1                 3                 0                 0                 0  
Lost to Follow-up                 2                 1                 2                 2                 0                 0                 1  
Refused to continue trial medication                 8                 0                 4                 2                 8                 1                 1  
Other Reason                 1                 0                 1                 1                 1                 2                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Treated set (TS): all patients treated with at least 1 dose of study medication

Reporting Groups
  Description
Main: Linagliptin 5mg QD Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
Main: Metformin 500mg BID Main Group: Patients received metformin 500mg BID, administered oral as tablet.
Main: Metformin 1000mg BID Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
Main: Linagliptin 2.5mg / Metformin 500mg BID Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
Main: Linagliptin 2.5mg / Metformin 1000mg BID Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
APG: Linagliptin 5mg QD

Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.

(Data up to week 12)

APG: Linagliptin 2.5mg / Metformin 1000mg BID

Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.

(Data up to week 12)

Total Total of all reporting groups

Baseline Measures
    Main: Linagliptin 5mg QD     Main: Metformin 500mg BID     Main: Metformin 1000mg BID     Main: Linagliptin 2.5mg / Metformin 500mg BID     Main: Linagliptin 2.5mg / Metformin 1000mg BID     APG: Linagliptin 5mg QD     APG: Linagliptin 2.5mg / Metformin 1000mg BID     Total  
Number of Participants  
[units: participants]
  147     145     144     147     147     71     72     873  
Age  
[units: years]
Mean (Standard Deviation)
  50.8  (10.5)     52.1  (9.6)     51.4  (10.4)     51.4  (10.2)     50.7  (9.4)     49.5  (11.6)     49.9  (11.7)     51.0  (10.3)  
Gender  
[units: participants]
               
Female     71     54     53     55     60     23     32     348  
Male     76     91     91     92     87     48     40     525  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group   [ Time Frame: Baseline and week 24 ]

2.  Primary:   The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)   [ Time Frame: Baseline and week 24 ]

3.  Primary:   The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG   [ Time Frame: Baseline and week 12 ]

4.  Secondary:   The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group   [ Time Frame: Week 24 (after first drug administration) ]

5.  Secondary:   The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG   [ Time Frame: Week 12 (after first drug administration) ]

6.  Secondary:   The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group   [ Time Frame: Week 24 (after first drug administration) ]

7.  Secondary:   The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG   [ Time Frame: Week 12 (after first drug administration) ]

8.  Secondary:   The Occurrence of Relative Efficacy Response in Main Group   [ Time Frame: From baseline until week 24 ]

9.  Secondary:   The Occurrence of Relative Efficacy Response in APG   [ Time Frame: From baseline until week 12 ]

10.  Secondary:   The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group   [ Time Frame: Baseline and week 24 ]

11.  Secondary:   The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG   [ Time Frame: Baseline and week 12 ]

12.  Secondary:   The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group   [ Time Frame: From baseline until week 24 ]

13.  Secondary:   The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG   [ Time Frame: From baseline until week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
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:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: NCT01708902     History of Changes
Other Study ID Numbers: 1288.18
Study First Received: October 16, 2012
Results First Received: April 8, 2015
Last Updated: April 8, 2015
Health Authority: China: Food and Drug Administration
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Vietnam: Ministry of Health