NCT04712266

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 12, 2021

Last Update Submit

January 14, 2021

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Outcome Measures

Primary Outcomes (2)

  • hypoglycemic excursions

    \< 50mg/dl

    180-360 minutes post meal

  • hyperglycemic excursions

    \>150mg/dl

    60-120 minutes post meal

Study Arms (2)

Insulin IV

ACTIVE COMPARATOR

calculated insulin rate

Drug: Insulin

Insulin and Glucagon IV

EXPERIMENTAL

calculated molar ratio insulin:glucagon

Drug: GlucagonDrug: Insulin

Interventions

GlucagonDRUG

calculated IV insulin:Glucagon molar ratio

Also known as: Glucagen Hypokit
Insulin and Glucagon IV
InsulinDRUG

calculated IV Insulin dose infused at a constant rate

Also known as: Human Insulin (Eli Lilly)
Insulin IVInsulin and Glucagon IV

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

MeSH Terms

Interventions

GlucagonInsulin

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulinInsulins

Study Officials

  • Bruce Bode, MD

    Atlanta Diabetes Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

September 15, 2020

Primary Completion

December 15, 2020

Study Completion

January 10, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)