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Aim: To study safety, efficacy and weight loss with ADO09, a co‐formulation of insulin A21G and pramlintide, in type 1 diabetes. Materials and Methods: A randomized, two‐arm ambulatory 16‐week study compared ADO09 with insulin lispro in 80 participants with type 1 diabetes. We compared changes of weight, glycated haemoglobin, glycaemic patterns during continuous glucose monitoring, and insulin doses at baseline and at the end of treatment. Results: A significant and continuing weight loss, the primary endpoint, was observed with ADO09 compared with lispro as prandial insulin. In the whole group, the weight loss with ADO09 relative to lispro was 2.1 kg. Glycaemic control was relatively good (7.7% mean glycated haemoglobin) in both groups and did not change during treatment. Prandial insulin doses were reduced by 21% in the ADO09 group, whereas basal insulin dosage was not modified. Gastrointestinal symptoms were more frequent with ADO09, but no clear difference in hypoglycaemia was observed. Conclusions: These results extend previous observations on the efficacy and safety of this insulin/pramlintide co‐formulation. They show a beneficial effect on weight, using less mealtime insulin and without increased hypoglycaemia. [ABSTRACT FROM AUTHOR]

Aim: Pramlintide improves postprandial glucose but requires additional injections. We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co‐formulation, in type 1 diabetes (T1D). Materials and Methods: This double‐blinded, randomized, two‐period cross‐over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low‐dose group (LD), n = 28] or 40‐75 U [high‐dose group (HD), n = 16]. Glycaemic responses through continuous glucose monitoring, and pharmacokinetics/pharmacodynamics profiles following mixed‐meal‐tolerance tests were evaluated at baseline and at the end of treatment. Results: Glucose increments from 0 to 4 h after mixed‐meal‐tolerance test (primary endpoint) were 39% (not statistically significantly) lower with ADO09 in the low‐dose group and 69% lower in the high‐dose group. Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: –8.2 ± 7.9 mg/dl, p =.0001; HD: –7.0 ± 10 mg/ml, p =.0127), and time‐in‐range (70–180 mg/dl) improved (LD: +4%, p =.0134; HD: +4%, p =.0432). Body weight declined significantly with ADO09 (LD: –0.8 kg; HD: –1.6 kg). Hypoglycaemic events were slightly more frequent with ADO09 versus aspart (LD: 142 vs. 115; HD: 96 vs. 79). Gastrointestinal events occurred more frequently with ADO09 but were generally transient, and no other safety signals were identified. Conclusions: In comparison with aspart, ADO09 was well tolerated and effective in T1D across a wide range of dosage, significantly improving the average blood glucose level and body weight during 24 days of ambulatory treatment. Meal test profiles confirmed improvement of glycaemic patterns and other responses with ADO09. [ABSTRACT FROM AUTHOR]