- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342484
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada
- 1218.56.11001 Boehringer Ingelheim Investigational Site
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Fort de France cedex, France
- 1218.56.33003 Boehringer Ingelheim Investigational Site
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Rouen, France
- 1218.56.33006 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1218.56.50202 Boehringer Ingelheim Investigational Site
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Guatemala, Guatemala
- 1218.56.50203 Boehringer Ingelheim Investigational Site
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Firenze, Italy
- 1218.56.39005 Boehringer Ingelheim Investigational Site
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Busan, Korea, Republic of
- 1218.56.82005 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1218.56.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1218.56.82002 Boehringer Ingelheim Investigational Site
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Suwon, Korea, Republic of
- 1218.56.82003 Boehringer Ingelheim Investigational Site
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Chihuahua, Mexico
- 1218.56.52008 Boehringer Ingelheim Investigational Site
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Guadalajara, Mexico
- 1218.56.52002 Boehringer Ingelheim Investigational Site
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León, Mexico
- 1218.56.52001 Boehringer Ingelheim Investigational Site
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Monterrey, Mexico
- 1218.56.52003 Boehringer Ingelheim Investigational Site
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Oaxaca, Mexico
- 1218.56.52004 Boehringer Ingelheim Investigational Site
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Gdansk, Poland
- 1218.56.48002 Boehringer Ingelheim Investigational Site
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Gliwice, Poland
- 1218.56.48001 Boehringer Ingelheim Investigational Site
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Warszawa, Poland
- 1218.56.48004 Boehringer Ingelheim Investigational Site
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Wroclaw, Poland
- 1218.56.48003 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
- 1218.56.70001 Boehringer Ingelheim Investigational Site
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Saratov, Russian Federation
- 1218.56.70003 Boehringer Ingelheim Investigational Site
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Ufa, Russian Federation
- 1218.56.70004 Boehringer Ingelheim Investigational Site
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Yekaterinburg, Russian Federation
- 1218.56.70006 Boehringer Ingelheim Investigational Site
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Texas
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San Antonio, Texas, United States
- 1218.56.01006 Boehringer Ingelheim Investigational Site
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Virginia
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Norfolk, Virginia, United States
- 1218.56.01004 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: linagliptin low dose
linagliptin low dose for children once daily
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comparison of different dosages of drug (low vs high) vs placebo
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EXPERIMENTAL: linagliptin high dose
linagliptin high dose for children once daily
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comparison of different dosages of drug (low vs high) vs placebo
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PLACEBO_COMPARATOR: placebo
matching placebo for each linagliptin dose once daily
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comparison of different dosages of drug (low vs high) vs placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
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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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Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State
Time Frame: Baseline and 4 weeks or 8 weeks or 12 weeks
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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.
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Baseline and 4 weeks or 8 weeks or 12 weeks
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Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
Other Study ID Numbers
- 1218.56
- 2009-017004-91 (EUDRACT_NUMBER: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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