Adocia Initiates Phase 2 Clinical Trial for M1Pram in Patients with Type 1 Diabetes
Adocia (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on diabetes treatment and other metabolic diseases, announced today the initiation of a Phase 2 study in type 1 diabetes (T1D). The purpose of the study is to confirm and optimize the safety and efficacy of M1Pram in comparison with insulin lispro (Humalog, Eli Lilly) in regard to glycemic control and body weight reduction.
“We are pleased to launch this ambitious study so rapidly. This Phase 2 study will allow us to evaluate a larger sample size and obtain additional data on M1Pram following the promising results in our previous studies,” said Olivier Soula, Deputy CEO and Director of R&D at Adocia “M1Pram could improve glycemic control and reduce weight for overweight and obese patients, something that no other insulin has been able to offer”.
About the Phase 2 study
This study evaluates the efficacy of M1Pram on body weight reduction and blood glucose control compared to insulin lispro (Humalog, Eli Lilly) after 16 weeks of treatment in 80 type 1 diabetes patients. Both products are administered in combination with basal insulin. Safety criteria are also being assessed. The study is designed as a multicentric, open-label, randomized, active-comparator controlled, two parallel arm trial. Glucose homeostasis is assessed using continuous blood glucose monitoring and patient satisfaction is appraised via a questionnaire. The study is conducted in Germany and has been approved by the German regulatory authority, the BfArM.
In September 2020, our Phase 1b study results showed a statistically improved Time-In-Range for patients treated with M1Pram vs. aspart (Novolog, NovoNordisk). Moreover, a significant average weight loss of 1.6 kg compared to baseline was observed in people treated with M1Pram. Patients treated with aspart observed an average weight gain of 0.4 kg. Additionally, after each treatment period, study participants completed a treatment satisfaction questionnaire. The data reflects the beneficial impact of M1Pram on individuals, 87% of them reported an improved appetite control, and 75% of the patients would recommend it to other people with diabetes.