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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01342484

Run by

Boehringer Ingelheim

People needed

40

Starts

2011-04-01

Expected to finish

2016-02-01

Last updated by the study team

2016-09-15

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• 1218.56.01006 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1218.56.01004 Boehringer Ingelheim Investigational Site — Norfolk, Virginia, United States
• 1218.56.11001 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
• 1218.56.33003 Boehringer Ingelheim Investigational Site — Fort de France Cedex, France
• 1218.56.33006 Boehringer Ingelheim Investigational Site — Rouen, France
• 1218.56.50202 Boehringer Ingelheim Investigational Site — Guatemala City, Guatemala
• 1218.56.50203 Boehringer Ingelheim Investigational Site — Guatemala City, Guatemala
• 1218.56.39005 Boehringer Ingelheim Investigational Site — Florence, Italy
• 1218.56.52008 Boehringer Ingelheim Investigational Site — Chihuahua City, 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 City, Mexico
• 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 — Warsaw, Poland
• 1218.56.48003 Boehringer Ingelheim Investigational Site — Wroclaw, Poland
• 1218.56.70001 Boehringer Ingelheim Investigational Site — Moscow, Russia
• 1218.56.70003 Boehringer Ingelheim Investigational Site — Saratov, Russia
• 1218.56.70004 Boehringer Ingelheim Investigational Site — Ufa, Russia
• 1218.56.70006 Boehringer Ingelheim Investigational Site — Yekaterinburg, Russia
• 1218.56.82005 Boehringer Ingelheim Investigational Site — Busan, South Korea
• 1218.56.82001 Boehringer Ingelheim Investigational Site — Seoul, South Korea
• 1218.56.82002 Boehringer Ingelheim Investigational Site — Seoul, South Korea
• 1218.56.82003 Boehringer Ingelheim Investigational Site — Suwon, South Korea

Full record on ClinicalTrials.gov

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