NCT03554486

Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy

Completed Phase 4 Results posted Last updated 18 August 2021

What this trial tests

Phase 4 trial testing Fiasp in Diabetes Mellitus, Type 1 in 27 participants. Completed in 30 March 2019.

Timeline

23 July 2018

Primary endpoint
30 March 2019

30 March 2019

Quick facts

Lead sponsor	Stanford University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	27
Start date	23 July 2018
Primary completion	30 March 2019
Estimated completion	30 March 2019
Sites	2 locations across United States

Drugs / interventions tested

• Fiasp
• Novolog (INSULIN ASPART) — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl Primary · 7 days (during 2nd half of 2-week intervention period)

Measured as percentage of time in range (days).

Group	Value	95% CI
Fiasp Insulin	78.4	± 9.3
Novolog Insulin	75.3	± 9.5

Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl Primary · 7 days (during 2nd half of 2-week intervention period)

Percentage of time in range (days) as a measure of hypoglycemia.

Group	Value	95% CI
Fiasp Insulin	2.3	± 2.0
Novolog Insulin	3.1	± 2.1

Mean Sensor Glucose in mg/dl Secondary · 7 days (during 2nd half of 2-week intervention period)

Mean sensor data over the second week of using a randomized, blinded insulin.

Group	Value	95% CI
Fiasp Insulin	146	± 12
Novolog Insulin	147	± 12

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Run-in Period

Serious: 0/28 (0%)

Deaths: 0/28

Fiasp Insulin

Serious: 0/19 (0%)

Deaths: 0/19

Novolog Insulin

Serious: 1/19 (5%)

Deaths: 0/19

Serious adverse events (1 terms)

Reaction	System	Run-in Period	Fiasp Insulin	Novolog Insulin
Infusion set failure	Skin and subcutaneous tissue disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Run-in Period	Fiasp Insulin	Novolog Insulin
Irritation/Inflammation	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Infusion set failure.

Data from ClinicalTrials.gov NCT03554486 adverse events section.

Sponsor's own description

This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.