T2GO - Dapagliflozin in T2DM Patients aged 10-24 years

• Research type

  Research Study

• Full title

  A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years.

• IRAS ID

  201273

• Contact name

  James E. Greening

• Contact email

  james.greening@uhl-tr.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2015-005041-31

• Clinicaltrials.gov Identifier

  NCT02725593

• Duration of Study in the UK

  3 years, 0 months, 10 days

• Research summary

  Diabetes Mellitus (DM) is a condition that causes a person's blood sugar level to become too high. There are two main types of DM: type 1 and type 2 with type 2 DM (T2DM) making up about 90% of all DM cases.
  DM is associated with severe side effects like vision loss and lower limb amputation. In 2012 DM was the direct cause of 1.5 million deaths.
  Until recently, T2DM was seen only in adults but it is now also occurring in children. Data from T2DM children for treatment are limited. Several oral blood sugar lowering medications are available for adults with T2DM, the only one approved for use in paediatric patients age 10 and older is metformin.

  Dapagliflozin is available on prescription for adult patients with T2DM. This clinical study will evaluate how safe and how effective the Dapagliflozin is in T2DM patients between the age of 10 and 24. Throughout the study, participants will continue their routine T2DM approved medications.

  Potential participants will undergo eligibility screening prior to enrolling on the study. Treatment will start with a 4-week lead-in phase where a placebo (no active substance) is given alongside diet and exercise advice. After the lead-in, participants will have a 1 in 2 chance (50% chance) to receive Dapagliflozin or placebo for 24 weeks. After this treatment period, all participants have the option to receive Dapagliflozin for the duration of a 28-week open label extension period for safety monitoring. This will be followed by a 4 week post treatment safety follow-up period.

  Approximately 54 participants between the age of 10 and 24 years will be allowed to take part in the study.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  16/EE/0196

• Date of REC Opinion

  14 Jul 2016

• REC opinion

  Further Information Favourable Opinion