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Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01342484
First received: April 26, 2011
Last updated: July 27, 2016
Last verified: July 2016
Results First Received: July 27, 2016  
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: placebo
Drug: BI1356 low dose
Drug: BI1356 high dose

  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
Randomised, double-blind, placebo-controlled parallel group dose-finding study of linagliptin over 12 weeks in children and adolescents, from 10 to 17 years of age, with type 2 diabetes mellitus. Due to serious Good clinical practice (GCP) breach, 1 patient excluded from all analyses. So protocol section has 40 subjects and participant flow has 39

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients suitable after screening underwent a 2-week open-label placebo run-in period before randomisation. Patients who successfully completed this period and who still met the inclusion/exclusion criteria were randomised to the 12-week randomised period in which they received either 1 of the 2 doses of linagliptin or placebo.

Reporting Groups
  Description
Placebo Matching placebo dose was administered orally once daily for 12 weeks
Linagliptin 1 mg Linagliptin 1 mg dose was administered orally once daily for 12 weeks
Linagliptin 5 mg Linagliptin 5 mg dose was administered orally once daily for 12 weeks

Participant Flow:   Overall Study
    Placebo   Linagliptin 1 mg   Linagliptin 5 mg
STARTED   15   10   14 
COMPLETED   13   10   13 
NOT COMPLETED   2   0   1 
Other Reasons                1                0                0 
Protocol Violation                0                0                1 
Withdrawal by Subject                1                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.
Treated set (TS) including all patients who were treated with at least one dose of study drug.

Reporting Groups
  Description
Placebo Matching placebo dose was administered orally once daily for 12 weeks
Linagliptin 1 mg Linagliptin 1 mg dose was administered orally once daily for 12 weeks
Linagliptin 5 mg Linagliptin 5 mg dose was administered orally once daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo   Linagliptin 1 mg   Linagliptin 5 mg   Total
Overall Participants Analyzed 
[Units: Participants]
 15   10   14   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.7  (2.0)   14.0  (1.8)   14.3  (2.1)   14.0  (1.9) 
Gender 
[Units: Participants]
       
Female   8   4   9   21 
Male   7   6   5   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State   [ Time Frame: Baseline and 4 weeks or 8 weeks or 12 weeks ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 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:  
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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01342484     History of Changes
Other Study ID Numbers: 1218.56
2009-017004-91 ( EudraCT Number: EudraCT )
Study First Received: April 26, 2011
Results First Received: July 27, 2016
Last Updated: July 27, 2016
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Guatemala: Ministry of Public Health and Social Assistance
Italy: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
United States: Food and Drug Administration