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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01342484
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: placebo Drug: BI1356 low dose Drug: BI1356 high dose Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2011
Primary Completion Date : February 2016
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342484


Locations
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
France
1218.56.33003 Boehringer Ingelheim Investigational Site
Fort de France cedex, France
1218.56.33006 Boehringer Ingelheim Investigational Site
Rouen, France
Guatemala
1218.56.50202 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
1218.56.50203 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
Italy
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
Mexico
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
Poland
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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01342484     History of Changes
Other Study ID Numbers: 1218.56
2009-017004-91 ( EudraCT Number: EudraCT )
First Posted: April 27, 2011    Key Record Dates
Results First Posted: September 15, 2016
Last Update Posted: September 15, 2016
Last Verified: July 2016

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