New Therapies for Children and Adolescents with Type 2 Diabetes? 

By Jeemin Kwon

A study is enrolling over 100 people with type 2 between the ages of 10 and 18 years, examining Jardiance and Tradjenta

Clinical Trials Identifier: NCT03429543

Trial name: Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents

Diabetes type: Type 2

What the trial is testing: This study is evaluating the efficacy and safety of Jardiance (empagliflozin) and Tradjenta (linagliptin) compared to placebo (“nothing” pill) in people with type 2 diabetes between 10-18 years old. Both Jardiance and Tradjenta are pills already approved for use in adults with type 2 diabetes.

What the trial is measuring: Researchers will record the change in A1C from the start of the study; other measures include change in fasting glucose, body weight, and blood pressure. We wish “time in range” were being measured – next time!

Why is this new/important? Currently, only metformin and insulin are officially approved for people with type 2 diabetes under the age of 18 – a much smaller toolbox than the many drug classes approved for adults with type 2. The need, however, continues to grow as more young people are diagnosed with type 2 and might benefit from new type 2 diabetes drugs. RISE, a recent study presented at the 2018 ADA conference, demonstrated that type 2 diabetes in youth is a very different condition than adult type 2; the researchers emphasized the importance of conducting more research and seeking evidence-based therapies for this age group. DINAMO will offer valuable information and if results are positive, could help provide more treatment options for young people with type 2

A similar trial studying Victoza in this age group has already been completed, and the data will be submitted to regulatory agencies later this year. 

Trial length: Six months

Trial locations: DINAMO is enrolling over 100 people across 30 trial locations in Arizona, Florida, Georgia, Idaho, New York, Tennessee, Texas, and other international locations; click here for a full list of locations.

Here are select eligibility criteria for enrollment:

• Between 10 and 18 years of age

• Diagnosed with type 2 diabetes for at least three months before first visit

• A1C between 6.5% and 10.5%

• Previously taken metformin and/or insulin for at least two months before first visit but not other diabetes medications

• BMI in 85^th percentile for respective gender and age group as defined by WHO (click here for chart girls’ chart, here for boys’ chart, and here for a BMI calculator); for example, for a 12-year-old girl, a BMI of over 21 kg/m² is the 85^th percentile

Where to get more information: Contact Boehringer Ingelheim at 1-800-243-0127 or email them at clintriage.rdg@boehringer-ingelheim.com