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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: placebo; Drug: BI1356 low dose; Drug: BI1356 high dose

• Registration Number: NCT01342484
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-07
• Results First Submitted: 2016-07-27
• Results First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Results First Posted: 2016-09-15
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	matching placebo for each linagliptin dose once daily
linagliptin low dose	BI1356 low dose	linagliptin low dose for children once daily
linagliptin high dose	BI1356 high dose	linagliptin high dose for children once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment	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

Name	Time	Method
Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State	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.
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment	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.

Trial Locations

Locations (25)

1218.56.52008 Boehringer Ingelheim Investigational Site; 🇲🇽 Chihuahua, Mexico

1218.56.11001 Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada

1218.56.33006 Boehringer Ingelheim Investigational Site; 🇫🇷 Rouen, France

1218.56.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

1218.56.82002 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1218.56.70001 Boehringer Ingelheim Investigational Site; 🇷🇺 Moscow, Russian Federation

1218.56.52004 Boehringer Ingelheim Investigational Site; 🇲🇽 Oaxaca, Mexico

1218.56.70006 Boehringer Ingelheim Investigational Site; 🇷🇺 Yekaterinburg, Russian Federation

1218.56.33003 Boehringer Ingelheim Investigational Site; 🇫🇷 Fort de France cedex, France

1218.56.70003 Boehringer Ingelheim Investigational Site; 🇷🇺 Saratov, Russian Federation

1218.56.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1218.56.50203 Boehringer Ingelheim Investigational Site; 🇬🇹 Guatemala, Guatemala

1218.56.39005 Boehringer Ingelheim Investigational Site; 🇮🇹 Firenze, Italy

1218.56.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1218.56.82005 Boehringer Ingelheim Investigational Site; 🇰🇷 Busan, Korea, Republic of

1218.56.82003 Boehringer Ingelheim Investigational Site; 🇰🇷 Suwon, Korea, Republic of

1218.56.52002 Boehringer Ingelheim Investigational Site; 🇲🇽 Guadalajara, Mexico

1218.56.52003 Boehringer Ingelheim Investigational Site; 🇲🇽 Monterrey, Mexico

1218.56.48004 Boehringer Ingelheim Investigational Site; 🇵🇱 Warszawa, Poland

1218.56.70004 Boehringer Ingelheim Investigational Site; 🇷🇺 Ufa, Russian Federation

1218.56.48001 Boehringer Ingelheim Investigational Site; 🇵🇱 Gliwice, Poland

1218.56.48003 Boehringer Ingelheim Investigational Site; 🇵🇱 Wroclaw, Poland

1218.56.52001 Boehringer Ingelheim Investigational Site; 🇲🇽 León, Mexico

1218.56.48002 Boehringer Ingelheim Investigational Site; 🇵🇱 Gdansk, Poland

1218.56.50202 Boehringer Ingelheim Investigational Site; 🇬🇹 Guatemala, Guatemala