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Completed

NCT Number: NCT01342484

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1218.56.11001 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

comparison of different dosages of drug (low vs high) vs placebo

BI1356 low dose

Drug

comparison of different dosages of drug (low vs high) vs placebo

BI1356 high dose

Drug

comparison of different dosages of drug (low vs high) vs placebo

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2011
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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