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

July 27, 2016 updated by: Boehringer Ingelheim

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
EXPERIMENTAL: linagliptin low dose
linagliptin low dose for children once daily
comparison of different dosages of drug (low vs high) vs placebo
EXPERIMENTAL: linagliptin high dose
linagliptin high dose for children once daily
comparison of different dosages of drug (low vs high) vs placebo
PLACEBO_COMPARATOR: placebo
matching placebo for each linagliptin dose once daily
comparison of different dosages of drug (low vs high) vs placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks or 8 weeks or 12 weeks
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.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (ESTIMATE)

April 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

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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