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Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00798161
First received: November 24, 2008
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: May 20, 2011  
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: BI 1356
Drug: BI 1356 + metformin
Drug: Bi 1356 + metformin
Drug: Metformin
Drug: metformin
Drug: matching 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Patients treated with matching placebo
M500 Twice Daily (BID) Patients treated with Metformin 500 mg BID
M1000 BID Patients treated with Metformin 1000 mg BID
Lina 5 Patients treated with Linagliptin 5 mg once daily (OD)
L2.5+M500 BID Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
L2.5 + M1000 BID Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
OL: L2.5+M1000 BID Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID

Participant Flow:   Overall Study
    Placebo     M500 Twice Daily (BID)     M1000 BID     Lina 5     L2.5+M500 BID     L2.5 + M1000 BID     OL: L2.5+M1000 BID  
STARTED     72     144     147     142     143     143     66  
COMPLETED     54     127     126     121     127     132     56  
NOT COMPLETED     18     17     21     21     16     11     10  
Adverse Event                 3                 4                 6                 6                 5                 2                 4  
Protocol Violation                 2                 1                 3                 3                 3                 2                 0  
Lost to Follow-up                 1                 3                 4                 3                 4                 0                 0  
Withdrawal by Subject                 5                 4                 5                 4                 2                 3                 1  
Other reason (incl. lack of efficacy)                 7                 5                 3                 5                 2                 4                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Patients treated with matching placebo
M500BID Patients treated with Metformin 500mg BID
M1000BID Patients treated with Metformin 1000mg BID
Lina5 Patients treated with Linagliptin 5mg OD
L2.5+M500BID Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
L2.5+M1000BID Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
L2.5+M1000BID (Open Label) Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
Total Total of all reporting groups

Baseline Measures
    Placebo     M500BID     M1000BID     Lina5     L2.5+M500BID     L2.5+M1000BID     L2.5+M1000BID (Open Label)     Total  
Number of Participants  
[units: participants]
 		  72     144     147     142     143     143     66     857  
Age  
[units: Years]
Mean ± Standard Deviation 		  55.7  ± 11.0     52.9  ± 10.4     55.2  ± 10.6     56.2  ± 10.8     55.6  ± 11.2     56.4  ± 10.7     53.5  ± 11.1     55.2  ± 10.8  
Gender  
[units: Patients]
 		               
Female     36     62     69     80     70     66     40     423  
Male     36     82     78     62     73     77     26     434  
Body Mass Index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation 		  28.62  ± 5.17     28.92  ± 4.83     29.52  ± 5.31     28.95  ± 4.67     29.66  ± 5.31     28.55  ± 4.80     28.81  ± 4.93     29.07  ± 4.97  
Glycosylated Hemoglobin A1 (HbA1C)  
[units: Percent]
Mean ± Standard Deviation 		  8.67  ± 0.95     8.66  ± 0.90     8.52  ± 0.87     8.70  ± 0.97     8.71  ± 0.95     8.68  ± 1.03     11.84  ± 1.42     8.91  ± 1.31  
Fasting plasma glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation 		  203.7  ± 51.2     191.2  ± 46.9     192.3  ± 52.8     195.3  ± 50.2     198.6  ± 60.2     196.9  ± 51.2     261.8  ± 80.9     200.2  ± 57.3  



  Outcome Measures
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1.  Primary:   HbA1c Change From Baseline at Week 24   [ Time Frame: Baseline and week 24 ]
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2.  Secondary:   HbA1c Change From Baseline at Week 6   [ Time Frame: Baseline and week 6 ]
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3.  Secondary:   HbA1c Change From Baseline at Week 12   [ Time Frame: Baseline and week 12 ]
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4.  Secondary:   HbA1c Change From Baseline at Week 18   [ Time Frame: Baseline and week 18 ]
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5.  Secondary:   FPG Change From Baseline at Week 24   [ Time Frame: Baseline and week 24 ]
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6.  Secondary:   FPG Change From Baseline at Week 2   [ Time Frame: Baseline and week 2 ]
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7.  Secondary:   FPG Change From Baseline at Week 6   [ Time Frame: Baseline and week 6 ]
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8.  Secondary:   FPG Change From Baseline at Week 12   [ Time Frame: Baseline and week 12 ]
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9.  Secondary:   FPG Change From Baseline at Week 18   [ Time Frame: Baseline and week 18 ]
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10.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 24   [ Time Frame: Baseline and Week 24 ]
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11.  Secondary:   Percentage of Patients With HbA1c<7.0 at Week 24   [ Time Frame: Baseline and Week 24 ]
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12.  Secondary:   Percentage of Patients With HbA1c <6.5% at Week 24   [ Time Frame: Baseline and Week 24 ]
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13.  Secondary:   Percentage of Patients With HbA1c < 6.5% at Week 24   [ Time Frame: Baseline and Week 24 ]
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14.  Secondary:   Percentage of Patients With HbA1c Lowering by 0.5% at Week 24   [ Time Frame: Baseline and week 24 ]
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15.  Secondary:   Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24   [ Time Frame: Baseline and week 24 ]
  Show Outcome Measure 15

16.  Secondary:   HbA1c Change From Baseline at Week 24 for Open-label Patients   [ Time Frame: Baseline and week 24 ]
  Show Outcome Measure 16

17.  Secondary:   FPG Change From Baseline at Week 24 for Open-label Patients   [ Time Frame: Baseline and week 24 ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  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
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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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00798161     History of Changes
Other Study ID Numbers: 1218.46, 2008-001640-40
Study First Received: November 24, 2008
Results First Received: May 20, 2011
Last Updated: July 10, 2012
Health Authority: Canada: Health Canada, Therapeutic Products Directorate
Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
Estonia: State Agency of Medicines, EE-5041Tartu
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
India: Drug Control General of India
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Sweden: Medical Products Agency Regional Ethics Committee of Uppsala
Tunisia: Direction de la Pharmacie et du Médicament (DPM) 31, Rue de Khartoum 1002 Tunis - Belvédère
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)