ADOCIA Announces M1Pram Phase 2 Trial Meets Primary Objective by Reducing Weight in Overweight People with Type 1 Diabetes
- Demonstrated weight loss vs. Humalog® (-2.13kg) over 4 months with progressive and continuous weight loss still ongoing at the end of study period.
- Both treatments were well tolerated and overall good glycemic control is maintained in both groups
- Better control of appetite expressed in patient satisfaction scoring after 16 weeks of treatment (82.4% with M1Pram vs. 43.2% with Humalog®)
- Selected for an oral communication at EASD 2022 (
European Association for the Study of Diabetes)
The fixed-ratio combination of M1 human insulin analog 100 Units/mL and pramlintide 600µg/mL, the only FDA-approved amylin analog (Symlin®, AstraZeneca), demonstrated statistically superior weight loss compared with insulin lispro 100 Units/mL. Full topline results will be communicated at EASD 2022.
“We are really pleased to confirm that M1Pram ensures weight loss of overweight type 1 patients as pramlintide is the only adjunct to insulin approved by FDA for people with type 1 diabetes.“ said
CT041 Topline Results
This parallel arm study, conducted by Profil in
- The weight loss of M1Pram vs Humalog over 4 months is -2.13kg (p=0.0045) in total population and -3.1kg (p=0.0155) in a subpopulation of patients with BMI>28kg/m2. During the period, a continuous weight decrease was observed and was still ongoing at the end of the study.
- Both treatments maintained HbA1c and Time-in-Range in patient population with mean HbA1c of 7.4% at baseline.
- Hypoglycemic event numbers are similar between the two treatments and no difference in severe hypoglycemia.
- M1Pram demonstrates overall a good safety profile. Total number of adverse events (excluding hypoglycemia) M1Pram vs Humalog, 76 vs. 38 were mainly driven by gastro-intestinal side effects as expected and documented in pramlintide literature.
- The reduction of daily prandial insulin dose for M1Pram treatment compared to baseline is more than 10% (no change in Humalog arm).
- The treatment satisfaction questionnaire clearly demonstrates a better control of appetite with M1Pram for 82.4% of patients (vs 43.2% with Humalog).
“This phase 2 study of M1Pram shows that a single injection with each meal is as easy to use and as efficient as Humalog for glycemic control without increasing the rate of hypoglycemia.” declared Dr.
“The results highlight that M1Pram could provide people with type 1 diabetes with the only insulin that improves control of appetite and lowers weight.”, declared
Pramlintide is the only product with weight loss effect that the FDA has approved as adjunct to insulin for people with Type 1 Diabetes; GLP1-RA being only approved in Type 2 diabetes. Weight management and obesity is a major burden for people with T1D in the
About M1Pram, an insulin/amylin combination
M1Pram is a fixed-ratio combination of insulin and amylin analogs, two hormones that are missing or misfunctioning in diabetes patients. In healthy people, insulin plays a hypoglycemic role and glucagon acts as a hyperglycemic agent while amylin has a central position controlling gastric emptying, well-being and glucagon secretion. In type 1 diabetic patients, insulin and amylin are absent due to the destruction of β-cells by the immune system. In type 2 diabetes, patients progressively lose the ability to produce endogenous insulin and amylin as the disease progresses.
Pramlintide, an amylin analog, is marketed since 2005 and when administered with insulin, has demonstrated that restoring this missing hormone has tremendous effects improving glycemic control, weight loss in overweight patients and well-being.
M1Pram as a fixed-ratio combination of pramlintide and insulin allows for fewer daily injections in comparison to marketed pramlintide treatment scheme which requires to be injected on top of insulin. Moreover M1Pram improves the safety profile of the use of pramlintide.
It’s based on 15-years of experience in protein formulation and diabetes,
1) The BioChaperone® technology for the development of new generation insulins and products combining insulins with other classes of hormones; 2) AdOral®, an oral peptide delivery technology; 3) AdoShell® Islets, an immunoprotective biomaterial for cell transplantation with a first application in pancreatic cells transplantation for patients with "brittle" diabetes.
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Margaux Puech Pays d’Alissac
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