AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp... | NCT05754424

Studies
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

NCT05754424

Sponsor

Arecor Limited

Status

Completed

Last Update Posted

Feb 16, 2024Actual

Enrollment

41Actual

Phase

Phase 1

Conditions

Diabetes Mellitus, Type 2

Interventions

AT278
NovoRapid
Humulin R 500 UNT/ML Injectable Solution

Countries

Austria

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

ID	Type	Description	Link
2022-001984-28	EudraCT Number

Official Title

A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.

Status Module

Record Verification Date

Feb 2024

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

Feb 27, 2023Actual

Primary Completion Date

Jan 18, 2024Actual

Completion Date

Feb 12, 2024Actual

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Mar 2, 2023

First Posted Date

Mar 3, 2023Actual

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

Feb 15, 2024

Last Update Posted Date

Feb 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.

Detailed Description

Not provided

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AT278	Experimental	Single subcutaneous injection of 0.5 U/kg	Drug: AT278 Drug: NovoRapid Drug: Humulin R 500 UNT/ML Injectable Solution
NovoRapid	Active Comparator	Single subcutaneous injection of 0.5 U/kg	Drug: AT278 Drug: NovoRapid Drug: Humulin R 500 UNT/ML Injectable Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AT278	Drug	Concentrated rapid acting insulin aspart	AT278 NovoRapid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the glucose infusion rate-time curve of insulin aspart		0 to 60 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening
Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
BMI within the range of 25 - 45 kg/m2 (both inclusive)

Exclusion Criteria:

Known or suspected hypersensitivity to IMPs or related products
Clinically significant concomitant disease or abnormal lab values
Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Unit, Medical University of Graz		Graz			Austria

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061267	Insulin Aspart

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided