A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes

A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon

This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.

Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.

Inclusion Criteria:

• Male or female patients aged between 18 and 64 years (both inclusive)
• Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
• Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit

Exclusion Criteria:

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