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

Tracking Information
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; (submitted: July 27, 2016)	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.
Original Primary Outcome Measures ICMJE; (submitted: April 26, 2011)	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; (submitted: July 27, 2016)	Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State [ Time Frame: Baseline and 4 weeks or 8 weeks or 12 weeks ]DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.; Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ]Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Original Secondary Outcome Measures ICMJE; (submitted: April 26, 2011)	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.
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
Condition ICMJE	Diabetes Mellitus, Type 2
Intervention ICMJE	Drug: placebo comparison of different dosages of drug (low vs high) vs placebo; Drug: BI1356 low dose comparison of different dosages of drug (low vs high) vs placebo; Drug: BI1356 high dose comparison of different dosages of drug (low vs high) vs placebo
Study Arms	Experimental: linagliptin low dose linagliptin low dose for children once daily Intervention: Drug: BI1356 low dose; Experimental: linagliptin high dose linagliptin high dose for children once daily Intervention: Drug: BI1356 high dose; Placebo Comparator: placebo matching placebo for each linagliptin dose once daily Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 16, 2016)	40
Original Estimated Enrollment ICMJE; (submitted: April 26, 2011)	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: Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus; Insufficient glycaemic control (i.e. an HbA1c > 6.5% and <= 10.5%) despite treatment with diet and exercise and/or metformin (>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be <= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation); Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies; C-peptide levels (serum) >= 1.5 ng/ml (at 90 min following a Boost challenge) Exclusion criteria: History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months; Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation; Treatment with weight reduction medications (including anti-obesity treatments)
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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