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

This study has been completed.
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: April 26, 2011
Last updated: July 27, 2016
Last verified: July 2016

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: placebo
Drug: BI1356 low dose
Drug: BI1356 high dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 40
Study Start Date: April 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linagliptin low dose
linagliptin low dose for children once daily
Drug: BI1356 low dose
comparison of different dosages of drug (low vs high) vs placebo
Experimental: linagliptin high dose
linagliptin high dose for children once daily
Drug: BI1356 high dose
comparison of different dosages of drug (low vs high) vs placebo
Placebo Comparator: placebo
matching placebo for each linagliptin dose once daily
Drug: placebo
comparison of different dosages of drug (low vs high) vs placebo


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01342484

United States, Texas
1218.56.01006 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
1218.56.01004 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
Canada, Quebec
1218.56.11001 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1218.56.33003 Boehringer Ingelheim Investigational Site
Fort de France cedex, France
1218.56.33006 Boehringer Ingelheim Investigational Site
Rouen, France
1218.56.50202 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
1218.56.50203 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
1218.56.39005 Boehringer Ingelheim Investigational Site
Firenze, Italy
Korea, Republic of
1218.56.82005 Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
1218.56.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1218.56.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1218.56.82003 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
1218.56.52008 Boehringer Ingelheim Investigational Site
Chihuahua, Mexico
1218.56.52002 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1218.56.52001 Boehringer Ingelheim Investigational Site
León, Mexico
1218.56.52003 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1218.56.52004 Boehringer Ingelheim Investigational Site
Oaxaca, Mexico
1218.56.48002 Boehringer Ingelheim Investigational Site
Gdansk, Poland
1218.56.48001 Boehringer Ingelheim Investigational Site
Gliwice, Poland
1218.56.48004 Boehringer Ingelheim Investigational Site
Warszawa, Poland
1218.56.48003 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Russian Federation
1218.56.70001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1218.56.70003 Boehringer Ingelheim Investigational Site
Saratov, Russian Federation
1218.56.70004 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
1218.56.70006 Boehringer Ingelheim Investigational Site
Yekaterinburg, Russian Federation
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim 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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017