A Phase II clinical trial that will test the efficacy of a medication for Type 1 Diabetes has been initiated.
Adocia, a clinical stage biopharmaceutical company focused on diabetes treatment and other metabolic diseases, has launched the Phase 2 study in Type 1 Diabetes to confirm and optimise the safety and efficacy of M1Pram in comparison with insulin lispro regarding glycaemic control and body weight reduction.
The study is designed as a multicentric, open-label, randomised, active-comparator controlled, two parallel arm trial. It will be conducted in Germany and has been approved by the German regulatory authority, the BfArM.
Improving glycaemic control
M1Pram is a fixed-ratio combination of insulin and amylin analogues, two hormones that are missing or misfunctioning in diabetes patients. In healthy people, insulin plays a hypoglycaemic role and glucagon acts as a hyperglycaemic agent, while amylin has a central position controlling gastric emptying, wellbeing, and glucagon secretion. In Type 1 diabetic patients, insulin and amylin are absent due to the destruction of β-cells by the immune system.
The study will evaluate the safety criteria and efficacy of M1Pram on body weight reduction and blood glucose control compared to insulin lispro after 16 weeks of treatment in 80 Type 1 Diabetes patients. Both products are administered in combination with basal insulin. Glucose homeostasis is assessed using continuous blood glucose monitoring and patient satisfaction is appraised via a questionnaire. For the trial, glucose homeostasis will be assessed using continuous blood glucose monitoring, and patient satisfaction will be appraised via a questionnaire.
Olivier Soula, Deputy CEO and Director of R&D at Adocia, said: “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.
“M1Pram could improve glycaemic control and reduce weight for overweight and obese patients, something that no other insulin has been able to offer.”
Phase Ib results
In September 2020, the results from the Phase 1b study showed a statistically improved Time-In-Range for patients treated with M1Pram compared to aspart, and 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, as 87% of them reported an improved appetite control, and 75% of the patients would recommend it to other people with diabetes.