New Therapies for Children and Adolescents with Type 2 Diabetes?
By Jeemin Kwon
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 85th 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 85th percentile
Where to get more information: Contact Boehringer Ingelheim at 1-800-243-0127 or email them at firstname.lastname@example.org