Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00915772
First received: June 2, 2009
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Linagliptin + metformin
Drug: Linagliptin+metformin
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In this study, 567 patients were entered and randomised, but only 566 were treated. Therefore the treated set (TS) comprises 566 patients.

Reporting Groups
  Description
M1000 Metformin 1000mg monotherapy twice daily
L2.5+M500 Linagliptin 2.5mg and metformin 500mg twice daily
L2.5+M1000 Linagliptin 2.5mg and metformin 1000mg twice daily

Participant Flow:   Overall Study
    M1000     L2.5+M500     L2.5+M1000  
STARTED     170     225     171  
COMPLETED     134     179     142  
NOT COMPLETED     36     46     29  
Adverse Event                 12                 13                 11  
Protocol Violation                 4                 1                 2  
Lost to Follow-up                 1                 2                 2  
Lack of Efficacy                 9                 15                 3  
Refused to continue trial medication                 6                 8                 4  
Any other reason                 4                 7                 7  



  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
M1000 Metformin 1000mg monotherapy twice daily
L2.5+M500 Linagliptin 2.5mg and metformin 500mg twice daily
L2.5+M1000 Linagliptin 2.5mg and metformin 1000mg twice daily
Total Total of all reporting groups

Baseline Measures
    M1000     L2.5+M500     L2.5+M1000     Total  
Number of Participants  
[units: participants]
  170     225     171     566  
Age  
[units: Years]
Mean ± Standard Deviation
  55.6  ± 10.7     56.0  ± 10.7     55.7  ± 10.8     55.8  ± 10.7  
Gender  
[units: Number]
       
Female     77     105     74     256  
Male     93     120     97     310  
Body Mass Index (BMI) continuous  
[units: kg/m2]
Mean ± Standard Deviation
  29.33  ± 5.22     29.06  ± 4.95     28.64  ± 4.79     29.01  ± 4.98  
Baseline weight  
[units: kg]
Mean ± Standard Deviation
  81.09  ± 18.92     79.17  ± 18.75     78.62  ± 16.86     79.58  ± 18.25  
Baseline Glycosylated haemoglobin (HbA1c) at baseline [1]
[units: percent]
Mean ± Standard Deviation
  7.48  ± 0.99     7.64  ± 1.04     7.35  ± 1.12     7.50  ± 1.06  
Fasting plasma glucose (FPG) at baseline [2]
[units: mg/dL]
Mean ± Standard Deviation
  156.585  ± 39.194     167.088  ± 44.633     153.721  ± 37.128     159.868  ± 41.206  
[1] Based upon non-missing data, n=559 (5:1:1 missing in each of the groups respectively)
[2] Based upon non-missing data, n=544 (6:10:6 missing in each of the groups respectively)



  Outcome Measures
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1.  Primary:   Frequency of Patients With Adverse Events (AEs)   [ Time Frame: 54 weeks ]

2.  Primary:   Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)   [ Time Frame: 54 weeks ]

3.  Primary:   Change From Baseline at Week 54 in Pulse Rate   [ Time Frame: 54 weeks ]

4.  Primary:   Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology   [ Time Frame: 54 weeks ]

5.  Primary:   Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry   [ Time Frame: 54 weeks ]

6.  Primary:   Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE   [ Time Frame: Baseline and drug stop (up to 54 weeks) + 7 days ]

7.  Secondary:   Change in HbA1c From Baseline Over Time   [ Time Frame: 54 weeks ]

8.  Secondary:   Number of Patients With HbA1c <7.0% After 54 Weeks   [ Time Frame: 54 weeks ]

9.  Secondary:   Number of Patients With HbA1c <6.5% Over Time   [ Time Frame: 54 weeks ]

10.  Secondary:   Number of Patients With HbA1c of at Least <0.5% Over Time   [ Time Frame: 54 weeks ]

11.  Secondary:   Change in FPG From Baseline Over Time   [ Time Frame: 54 weeks ]

12.  Secondary:   Number of Patients With Rescue Therapy   [ Time Frame: 54 weeks ]

13.  Secondary:   Change in HbA1c From Baseline Over Time   [ Time Frame: 78 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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: NCT00915772     History of Changes
Other Study ID Numbers: 1218.52, 2008-008494-59
Study First Received: June 2, 2009
Results First Received: June 13, 2012
Last Updated: December 11, 2013
Health Authority: Canada: Health Canada
Croatia: Agency for Medicinal Product and Medical Devices
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Sweden: Regional Ethical Review Board
Tunisia: Ministry of Public Health
Ukraine: State Pharmacological Center - Ministry of Health