A Trial to Investigate Hyperglycemic and Hypoglycemic Exc... | NCT04712266

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

NCT04712266

Sponsor

Abvance Therapeutics

Status

Completed

Last Update Posted

Jan 15, 2021Actual

Enrollment

15Actual

Phase

Early Phase 1

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Interventions

Glucagon
Insulin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Jan 10, 2021Actual

First Submitted Date

Jan 12, 2021

First Submission Date that Met QC Criteria

Jan 14, 2021

First Posted Date

Jan 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2021

Last Update Posted Date

Jan 15, 2021Actual

Name	Class
T1D Exchange, United States	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin IV	Active Comparator	calculated insulin rate	Drug: Insulin
Insulin and Glucagon IV	Experimental	calculated molar ratio insulin:glucagon	Drug: Glucagon Drug: Insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucagon	Drug	calculated IV insulin:Glucagon molar ratio	Insulin and Glucagon IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hypoglycemic excursions	< 50mg/dl	180-360 minutes post meal
hyperglycemic excursions	>150mg/dl	60-120 minutes post meal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce Bode, MD	Atlanta Diabetes Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atlanta Diabetes Associates		Atlanta	Georgia	30318	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005934	Glucagon
D007328	Insulin

Ancestor Terms

ID	Term
D052336	Proglucagon
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided