Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT01342484 |
Recruitment Status
:
Completed
First Posted
: April 27, 2011
Results First Posted
: September 15, 2016
Last Update Posted
: September 15, 2016
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Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
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Tracking Information | ||||
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First Submitted Date ICMJE | April 26, 2011 | |||
First Posted Date ICMJE | April 27, 2011 | |||
Results First Submitted Date | July 27, 2016 | |||
Results First Posted Date | September 15, 2016 | |||
Last Update Posted Date | September 15, 2016 | |||
Study Start Date ICMJE | April 2011 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
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Original Primary Outcome Measures ICMJE |
The primary efficacy endpoint in this trial is the change from baseline in Glycosylated Haemoglobin (HbA1c) (%) after 12 weeks of treatment [ Time Frame: 12 weeks ] | |||
Change History | Complete list of historical versions of study NCT01342484 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
The secondary efficacy endpoint is the change from baseline in fasting plasma glucose (mmol/L) after 12 weeks of treatment [ Time Frame: 12 weeks ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes | |||
Official Title ICMJE | A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus | |||
Brief Summary | The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE |
112 | |||
Actual Study Completion Date | February 2016 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 10 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, France, Guatemala, Italy, Korea, Republic of, Mexico, Poland, Russian Federation, United States | |||
Removed Location Countries | Australia, New Zealand, Peru | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01342484 | |||
Other Study ID Numbers ICMJE | 1218.56 2009-017004-91 ( EudraCT Number: EudraCT ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Eli Lilly and Company | |||
Investigators ICMJE |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |