DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents (DINAMO)
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) .
Study phase: III
Study phase (if other): DIabetes study of liNAgliptin and eMpagliflozin in children and adolescents (DINAMO)
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
To pre-qualify for this study, a potential participant must: - be 10 to 17 years of age. -Have been diagnosed with type 2 diabetes for at least 8 weeks. - Be treated with: * diet and exercise plus metformin at a stable dose for at least 8 weeks or not tolerating metformin AND/OR *Diet and exercise, plus stable long-acting or multiple dose injection insulin therapy for at least 8 weeks, OR *No current active treatment (including discontinuation of metformin for at least 12 weeks) or have never received treatment.
Primary disease category: Diabetes & Endocrine System
Sponsor: Boehringer Ingelheim
Protocol number: 1218-0091
Projected enrollment dates: February 2021 to May 2021
Official study title: A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents