Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Mini-Dose Glucagon for Adults With Type 1 Diabetes: A Study to Assess the Efficacy and Safety of Mini-dose Glucagon for Treatment of Non-severe Hypoglycemia in Adults With Type 1 Diabetes
The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).
There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2)
Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension
Phase.
1. Run-in Phase:
Prior to commencing the crossover trial, study enrollment will begin with a 2 week
run-in phase to assess hypoglycemia eligibility and compliance.
2. Crossover Trial Phase:
The Crossover Trial Phase will consist of two (3-week) periods.
The Crossover Trial Phase will include up to 24 participants who complete these study
periods. Participants who do not complete both periods or who do not have at least one
event during both periods may be replaced.
During the Crossover Trial Phase participants will be randomized into two groups: (1)
Group A will use mini-dose glucagon in period 1 and oral glucose tablets in period 2 and
(2) Group B will use oral glucose tablets in period 1 and mini-dose glucagon in period
2. Each group with follow the applicable treatment arm according to their randomized
group.
3. Extension Phase:
The Post-Crossover Trial phase will commence upon completion of the second 3-week period of
the Crossover Trial Phase. Participants will have a 3 week phase during which time they will
decide whether to use mini-dose glucagon or glucose tablets to treat each non-severe
hypoglycemic event or to prevent hypoglycemia.
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