At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 26 enrolled

Drug / intervention

G-Pen Mini™ (glucagon injection) +1 moredrug

Likely dose

G-Pen Mini™ (glucagon injection) 69 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02411578

NCT02411578Phase 2Completed

Compare CT.gov

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

Jaeb Center for Health Research·interventional·Posted Apr 8, 2015·Updated Mar 3, 2020

In Brief

A Phase 2 clinical trial evaluating G-Pen Mini™ (glucagon injection) and Glucose Tablets for Diabetes Mellitus, Type 1. Completed, enrolled 26 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes Mellitus, Type 1

CountriesUnited States

CollaboratorsXeris Pharmaceuticals

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

First PostedApr 2015

Enrollment StartSep 2015

Primary CompletionApr 2016

Study CompletionMay 2016

TodayJul 2026

First PostedApr 8, 2015

Enrollment StartSep 1, 2015

Primary CompletionApr 1, 2016

Study CompletionMay 1, 2016

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 11.2 years ago

Interventions

G-Pen Mini™ (glucagon injection)drug

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)

Glucose Tabletsother

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)