Pramlintide-insulin co-formulation improves time in vary in kind 1 diabetes

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MeiffrenG, et al. 197-OR. Presented at: Scientific Sessions of the American Diabetes Association; 25-29 June 2021 (virtual meeting).

Disclosure:
Meiffren reports that he is an employee and shareholder of Adocia. Please refer to the executive summary for all relevant financial information from the other authors.

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ADO09, a co-formulation of pramlintide and insulin A21G, was linked to better glucose levels, improved time in area, and more weight loss in people with type 1 diabetes compared to insulin aspart, according to a moderator.

“ADO09 is a new and innovative co-formulation of two hormones that are missing in type 1 diabetes: insulin and its little sister amylin, which is co-secreted by the pancreas with insulin.” Gregory Meiffren, PhD, Director of Clinical Development, PKPD, and Biology at Adocia, told Healio. “When we compared the effects of ADO09 with that of insulin aspart, one of the gold standard prandial insulins, ADO09 improved postprandial glycemic control, reduced insulin doses and lowered body weight in patients with type 1 diabetes who took high doses of insulin every day. ”

Meiffren is Director of Clinical Development, PKPD and Biology at Adocia.

Meiffren presented results from the second part of a two-part clinical study at the Scientific Sessions of the American Diabetes Association.

In a randomized, double-blind clinical study, 16 participants with type 1 diabetes (93.8% men; mean age 46.5 years) were randomly assigned to ADO09 or insulin aspart for 24 days. After a washout period of 5 to 7 days, the participants switched to the opposite therapy for 24 days. Follow-up examinations were performed 7 to 15 days after the last dose.

ADO09 improves glucose and CGM metrics

After 24 days, ADO09 reduced the incremental area under the glucose curve between 0 and 4 hours in a mixed meal glucose tolerance test by 69% (P = 0.0266) and delta 1 hour plasma glucose by 82 mg / dL (P <. 0001) compared to insulin aspart. The rate of gastric emptying, measured by the absorption of paracetamol, was 50% lower with ADO09 than with insulin aspart.

Participants who took ADO09 had 58 minutes more time in the range between 70 mg / dL and 170 mg / dL (P = .0432) and 63 minutes more time in the range between 80 mg / dL and 140 mg / dL (P =. 0107) compared with insulin aspart. ADO09 lowered the time over 180 mg / dL by 80 minutes (P = 0.0049) and lowered the mean 24-hour blood sugar by 7 mg / dL (P = 0.0127) compared to insulin aspart.

Those who took ADO09 needed 12 units less prandial insulin per day compared to insulin aspart (P = 0.0004). ADO09 was also associated with an average decrease in body weight of 1.6 kg over 24 days, while participants taking insulin aspart gained an average of 0.4 kg body weight.

“Our results show that the fixed combination of the two hormones attenuates the postprandial blood sugar fluctuations, which are still the most difficult time of the day to control in type 1 diabetes,” said Meiffren. “In addition, reaching blood sugar goals usually requires intensive insulin therapy, which, however, leads to body weight gain. Since the obesity epidemic is now also affecting type 1 diabetics, it is an interesting prospect to develop a postprandial co-formulation that reduces body weight. “

No severe hypoglycaemia was observed

No serious side effects from ADO09 were reported during the study. Those who took ADO09 reported more gastrointestinal events and decreased appetite. Meiffren found that these are consistent with the known effects of Pramlintide (Symlin, AstraZeneca).

No major hypoglycemic events were observed during the study. There were slightly more hypoglycemic episodes with ADO09 compared to insulin aspart.

Meiffren said that a clinical phase 2 study with Profil is currently being carried out in Germany to compare ADO09 with insulin lispro (Humalog, Eli Lilly) in a parallel, open study with 80 participants with type 1 diabetes.

“Key endpoints will be glycemic control, which will be assessed using HbA1c change from baseline and continuous glucose monitoring and body weight change as we will include subjects with a body mass index above 25 kg / m²,” said Meiffren. “This study should allow us to design the phase 3 study in patients with type 1 diabetes with multiple daily injections. We are also working on the development of ADO09 in patients with type 2 diabetes. Indeed, this population can benefit from the combined formulation of insulin and amylin as they generally have weight problems. “

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Scientific meetings of the American Diabetes Association

Scientific meetings of the American Diabetes Association