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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01342484
First received: April 26, 2011
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:
  • The primary efficacy endpoint in this trial is the change from baseline in Glycosylated Haemoglobin (HbA1c) (%) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary efficacy endpoint is the change from baseline in fasting plasma glucose (mmol/L) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The key secondary endpoint in this trial is DPP-4 inhibition (%) at trough at steady state [ Time Frame: 4 weeks or 8 weeks or 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 117
Study Start Date: April 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342484

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Illinois
1218.56.01003 Boehringer Ingelheim Investigational Site Recruiting
Park Ridge, Illinois, United States
United States, Ohio
1218.56.01005 Boehringer Ingelheim Investigational Site Recruiting
Akron, Ohio, United States
United States, Texas
1218.56.01006 Boehringer Ingelheim Investigational Site Recruiting
San Antonio, Texas, United States
United States, Virginia
1218.56.01004 Boehringer Ingelheim Investigational Site Recruiting
Norfolk, Virginia, United States
Australia, Western Australia
1218.56.61001 Boehringer Ingelheim Investigational Site Not yet recruiting
Subiaco, Western Australia, Australia
Canada, Quebec
1218.56.11001 Boehringer Ingelheim Investigational Site Recruiting
Montreal, Quebec, Canada
France
1218.56.33003 Boehringer Ingelheim Investigational Site Recruiting
Fort de France cedex, France
1218.56.33002 Boehringer Ingelheim Investigational Site Recruiting
Lille, France
1218.56.33005 Boehringer Ingelheim Investigational Site Recruiting
Reims, France
1218.56.33006 Boehringer Ingelheim Investigational Site Recruiting
Rouen, France
1218.56.33008 Boehringer Ingelheim Investigational Site Recruiting
Saint Denis Cedex, France
1218.56.33009 Boehringer Ingelheim Investigational Site Recruiting
SAINT PIERRE Cedex, France
Guatemala
1218.56.50202 Boehringer Ingelheim Investigational Site Not yet recruiting
Guatemala, Guatemala
1218.56.50203 Boehringer Ingelheim Investigational Site Not yet recruiting
Guatemala, Guatemala
1218.56.50204 Boehringer Ingelheim Investigational Site Not yet recruiting
Zacapa, Guatemala
Italy
1218.56.39001 Boehringer Ingelheim Investigational Site Recruiting
Chieti, Italy
1218.56.39005 Boehringer Ingelheim Investigational Site Recruiting
Firenze, Italy
1218.56.39004 Boehringer Ingelheim Investigational Site Recruiting
Genova, Italy
1218.56.39006 Boehringer Ingelheim Investigational Site Recruiting
Messina, Italy
1218.56.39003 Boehringer Ingelheim Investigational Site Recruiting
Napoli, Italy
1218.56.39007 Boehringer Ingelheim Investigational Site Recruiting
Palermo, Italy
1218.56.39008 Boehringer Ingelheim Investigational Site Recruiting
Parma, Italy
Korea, Republic of
1218.56.82005 Boehringer Ingelheim Investigational Site Recruiting
Busan, Korea, Republic of
1218.56.82001 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1218.56.82002 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1218.56.82003 Boehringer Ingelheim Investigational Site Recruiting
Suwon, Korea, Republic of
Mexico
1218.56.52002 Boehringer Ingelheim Investigational Site Recruiting
Guadalajara, Mexico
1218.56.52001 Boehringer Ingelheim Investigational Site Not yet recruiting
León, Mexico
1218.56.52003 Boehringer Ingelheim Investigational Site Recruiting
Monterrey, Mexico
1218.56.52004 Boehringer Ingelheim Investigational Site Recruiting
Oaxaca, Mexico
New Zealand
1218.56.64001 Boehringer Ingelheim Investigational Site Recruiting
Greenlane East Auckland NZ, New Zealand
1218.56.64002 Boehringer Ingelheim Investigational Site Recruiting
Wellington South, New Zealand
Poland
1218.56.48002 Boehringer Ingelheim Investigational Site Terminated
Gdansk, Poland
1218.56.48001 Boehringer Ingelheim Investigational Site Completed
Gliwice, Poland
1218.56.48004 Boehringer Ingelheim Investigational Site Recruiting
Warszawa, Poland
1218.56.48003 Boehringer Ingelheim Investigational Site Recruiting
Wroclaw, Poland
Russian Federation
1218.56.70005 Boehringer Ingelheim Investigational Site Recruiting
Kazan, Russian Federation
1218.56.70001 Boehringer Ingelheim Investigational Site Recruiting
Moscow, Russian Federation
1218.56.70003 Boehringer Ingelheim Investigational Site Recruiting
Saratov, Russian Federation
1218.56.70004 Boehringer Ingelheim Investigational Site Recruiting
Ufa, Russian Federation
1218.56.70006 Boehringer Ingelheim Investigational Site Recruiting
Yekaterinburg, Russian Federation
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01342484     History of Changes
Other Study ID Numbers: 1218.56, 2009-017004-91
Study First Received: April 26, 2011
Last Updated: October 7, 2014
Health Authority: Australia: Human Research Ethics Committee
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Guatemala: Ministry of Public Health and Social Assistance
Italy: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
New Zealand: Medsafe
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Pharmacological Committee, Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
United States: Food and Drug Administration

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
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014