NCT01342484

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
9 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

July 1, 2016

Enrollment Period

4.8 years

First QC Date

April 26, 2011

Results QC Date

July 27, 2016

Last Update Submit

July 27, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment

    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 Outcomes (2)

  • Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State

    Baseline and 4 weeks or 8 weeks or 12 weeks

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment

    Baseline and 12 weeks

Study Arms (3)

linagliptin low dose

EXPERIMENTAL

linagliptin low dose for children once daily

Drug: BI1356 low dose

linagliptin high dose

EXPERIMENTAL

linagliptin high dose for children once daily

Drug: BI1356 high dose

placebo

PLACEBO COMPARATOR

matching placebo for each linagliptin dose once daily

Drug: placebo

Interventions

placeboDRUG

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

placebo
BI1356 low doseDRUG

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

linagliptin low dose
BI1356 high doseDRUG

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

linagliptin high dose

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

1218.56.01006 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.56.01004 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

1218.56.11001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1218.56.33003 Boehringer Ingelheim Investigational Site

Fort de France Cedex, France

Location

1218.56.33006 Boehringer Ingelheim Investigational Site

Rouen, France

Location

1218.56.50202 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1218.56.50203 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1218.56.39005 Boehringer Ingelheim Investigational Site

Florence, Italy

Location

1218.56.52008 Boehringer Ingelheim Investigational Site

Chihuahua City, Mexico

Location

1218.56.52002 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1218.56.52001 Boehringer Ingelheim Investigational Site

León, Mexico

Location

1218.56.52003 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1218.56.52004 Boehringer Ingelheim Investigational Site

Oaxaca City, Mexico

Location

1218.56.48002 Boehringer Ingelheim Investigational Site

Gdansk, Poland

Location

1218.56.48001 Boehringer Ingelheim Investigational Site

Gliwice, Poland

Location

1218.56.48004 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1218.56.48003 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

1218.56.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.56.70003 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

1218.56.70004 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1218.56.70006 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1218.56.82005 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1218.56.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.56.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.56.82003 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 15, 2016

Results First Posted

September 15, 2016

Record last verified: 2016-07

Locations

PL(4)CA(1)RU(4)GU(2)ME(5)IT(1)KR(4)US(2)FR(2)