inRange
Research type
Research Study
Full title
A 12-week randomized controlled trial to compare TOUJEO® and TRESIBA® in terms of glucose values in target range and variability during continuous glucose monitoring in patients with type 1 diabetes mellitus.
IRAS ID
270157
Contact name
Shenaz Ramtoola
Contact email
Sponsor organisation
Sanofi Aventis Groupe
Eudract number
2017-002756-91
Duration of Study in the UK
0 years, 8 months, 22 days
Research summary
Research Summary
Type 1 Diabetes Mellitus (T1DM) is a form of diabetes in which patients produce very little or no insulin. Many patients with T1DM require multiple daily injections (MDI) combining long acting insulin (usually given once a day) and rapid acting insulin (given before meals). This treatment is designed to minimise fluctuations in blood glucose levels which may contribute to disease of blood vessels and other diabetic complications.
HbA1c is a measurement of average blood glucose levels over a two to three-month period which does not detect these fluctuations. Continuous glucose monitoring (CGM) is a more effective way of measuring these fluctuations. Toujeo and Tresiba are forms of long acting insulin, injected once a day, which have a long blood sugar-lowering effect resulting in less fluctuations in blood glucose levels and better outcomes for patients with T1DM. This phase 4, multicentre, randomized, 12-week open-label study is designed to explore similarities and differences between Toujeo and Tresiba using CGM.
The study is planned to be conducted across European countries and the United States. Participants will be between the ages of 18 and 70 years with a diagnosis of T1DM. They must already have been on an MDI treatment regime for at least one year. Participants will be randomised to switch from their usual long acting insulin to receive either Toujeo or Tresiba in accordance with the National Product Label. Study participation length will be approximately 18 weeks. Once screened and confirmed as eligible, participants will undergo a 4-week run in phase during which their current insulin regime and CGM will be stabilised. After this they will be randomised to receive and will enter the 12-week open label treatment period, during which they will switch to study treatment with either Toujeo or Tresiba. Throughout the run in and treatment periods participants will be followed up at weekly intervals either by telephone call or by visiting the site.Summary of Results
Conclusion:
The primary objective of this study conducted in patients with T1DM insufficiently controlled with their previous insulin therapy was met, as 10% relative non-inferiority of Toujeo over Tresiba was demonstrated on the percent time in glucose range of ≥70 to ≤180 mg/dL obtained from CGM metrics at Week 12. The 10% relative non-inferiority was also demonstrated for the glucose variability measured by total CV. Superiority of Toujeo in percent time in glucose range of ≥70 to ≤180 mg/dL was not demonstrated. Similar incidence of hypoglycemia events was observed in both treatment groups. Overall, the safety profile of Toujeo and Tresiba in this population was consistent with the known safety profile of each product, and no unexpected safety findings were identified over the 12-weeks treatment period.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0327
Date of REC Opinion
24 Feb 2020
REC opinion
Further Information Favourable Opinion