NCT02411578

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	G-Pen Mini™ (glucagon injection)	1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (150 µg of glucagon per syringe)
OTHER	Glucose Tablets	1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (5 grams of fast-acting carbohydrates (D-Glucose) per tablet)

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2015-04-08
• Last updated: 2020-03-03
• Results posted: 2017-10-23

Locations

5 sites across 1 country: United States