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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01342484
First received: April 26, 2011
Last updated: September 19, 2014
Last verified: September 2014

April 26, 2011
September 19, 2014
April 2011
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01342484 on ClinicalTrials.gov Archive Site
  • The secondary efficacy endpoint is the change from baseline in fasting plasma glucose (mmol/L) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoint in this trial is DPP-4 inhibition (%) at trough at steady state [ Time Frame: 4 weeks or 8 weeks or 12 weeks ] [ Designated as safety issue: No ]
The secondary efficacy endpoint is the change from baseline in fasting plasma glucose (mmol/L) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
117
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
  2. 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)
  3. Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
  4. C-peptide levels (serum) >= 1.5 ng/ml (at 90 min following a Boost challenge)

Exclusion criteria:

  1. History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
  2. Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
  3. Treatment with weight reduction medications (including anti-obesity treatments)
Both
10 Years to 17 Years
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States,   Canada,   France,   Guatemala,   Italy,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Russian Federation
 
NCT01342484
1218.56, 2009-017004-91
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP