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

Type 1 Diabetes Mellitus With Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712266
• Other study ID #: ABV201
• Status: Completed
• Phase: Early Phase 1
• Start date: September 15, 2020
• Est. completion date: January 10, 2021

Study information

• Verified date: January 2021
• Source: Abvance Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 10, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus With Hypoglycemia

Intervention

Drug:
• Glucagon
calculated IV insulin:Glucagon molar ratio
• Insulin
calculated IV Insulin dose infused at a constant rate

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Abvance Therapeutics	T1D Exchange, United States

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoglycemic excursions	< 50mg/dl	180-360 minutes post meal
Primary	hyperglycemic excursions	>150mg/dl	60-120 minutes post meal