The Efficacy and Safety of Faster Insulin Aspart (Fiasp ) Compared to Conventional Insulin Aspart (NovoLog ) as Correction Bolus

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    45
  • sponsor
    Mountain Diabetes and Endocrine Center
Updated on 27 January 2021
insulin
hyperglycemia
hemoglobin a1c
glycosylated hemoglobin
hypoglycemia
severe hypoglycaemia
novolog
fiasp

Summary

The purpose of this investigator-initiated trial is to compare the efficacy in terms of time to recovery from hyperglycemia as measured by time to arrest of hyperglycemic excursion ("glucose plateau point", primary endpoint) and return to premeal glucose target if feasible (secondary endpoint) between Fiasp and conventional insulin aspart when used as a correction bolus. These endpoints will be determined by CGM (Dexcom) from data exported from the Dexcom Clarity program.

Description

Patients with type 1 DM using CSII require bolus insulin for two purposes: first, to cover carbohydrate intake to control postprandial glucose, and second, to correct episodes of hyperglycemia. The latter function is referred to as a "correction dose" or "correction bolus". Insulin pumps have bolus calculators which calculate correction doses based on the patient's individualized BG target and insulin sensitivity factor (ISF). Rapid-acting insulin analogues delivered by pump typically require 2 to 4 hours to fully correct an acute hyperglycemic episode, and sometimes multiple correction doses are needed to normalize the blood glucose level. This can be frustrating for patients, particularly when a correction bolus is necessary in addition to a meal bolus; frequently, patients must wait for the correction bolus to take effect and delay eating until the blood glucose has begun to normalize to avoid severe postprandial hyperglycemia. There is consequently an unmet need in insulin delivery, and in particular in CSII, for an insulin which can correct a hyperglycemic episode more rapidly than is currently possible with rapid-acting insulin analogues.

Faster insulin aspart (Fiasp) is a novel formulation of insulin aspart with an accelerated time-action profile which results in twice the exposure to insulin and 74% greater insulin action within the first 30 minutes after injection compared to conventional insulin aspart. This results in twice-as-fast onset of appearance in the bloodstream (4 vs. 9 min compared to conventional insulin aspart) which has been demonstrated to reduce postprandial glucose levels in patients with type 1 DM using CSII. Theoretically, this faster insulin action would be useful in correction dosing during acute episodes of hyperglycemia to normalize the blood glucose level more rapidly than is currently possible with conventional insulin aspart (NovoLog).

Many patients with type 1 DM using CSII now also use continuous glucose monitoring (CGM) for making insulin dosing decisions. Currently the FDA has approved 2 CGM systems for nonadjunctive use in bolus insulin dose calculations. Only one of these systems, the Dexcom, reads continuously to the patient and has alarms to warn of impending episodes of hyper- or hypoglycemia, and this is the system used most commonly by patients with type 1 DM using open-loop CSII. Patients now incorporate the Dexcom trend arrow, which depicts the rate and direction of glucose change, into the correction dose calculation, and recommendations on how to incorporate CGM information into correction dose calculations have recently been updated based on an expert consensus report. However, these guidelines were created for use with rapid acting insulin analogues. How they might need to be modified for use with Fiasp (the first and only ultra-rapid insulin analogue) is not known.

The purpose of this investigator-initiated trial is to compare the efficacy in terms of time to recovery from hyperglycemia as measured by time to arrest of hyperglycemic excursion ("glucose plateau point", primary endpoint) and return to premeal glucose target if feasible (secondary endpoint) between Fiasp and conventional insulin aspart when used as a correction bolus. These endpoints will be determined by CGM (Dexcom) from data exported from the Dexcom Clarity program.

Study hypothesis:

Compared to conventional insulin aspart, Fiasp will correct hyperglycemia (defined as arrest of rise of blood glucose, following correction bolus, ie, GPP ) faster than conventional insulin aspart in subjects with type 1 DM using CSII.

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment Aspart, Faster Insulin Aspart (Fiasp®)
Clinical Study IdentifierNCT04414579
SponsorMountain Diabetes and Endocrine Center
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Autoimmune disease or Diabetes Mellitus Types I and II or Diabetes Mellitus or Insulin dependent diabetes mellitus or Diabetes Mellitus, Type 1 or Dia...?
Do you have any of these conditions: Diabetes Mellitus, Type 1 or Diabetes Mellitus Types I and II or Diabetes Mellitus or type 1 diabetes or Autoimmune disease or insulin-dependent diabe...?
Do you have any of these conditions: Insulin dependent diabetes mellitus or Diabetes Mellitus, Type 1 or diabetes type 1 or diabetes mellitus type 1 or insulin-dependent diabetes or Diabe...?
Do you have any of these conditions: Insulin dependent diabetes mellitus or type i diabetes mellitus or diabetes type 1 or type 1 diabetes mellitus or Autoimmune disease or insulin-depend...?
Male and female patients > 18 years of age
Type 1 DM of > 1 year duration
Use of any open loop insulin pump, Tandem T-Slim with Basal IQ, Insulet Omnipod Dash, or any other investigator-approved insulin pumps with Dexcom CGM G5, G6, or newer version for > 6 months
Good baseline glycemic control (HbA1c < 7.5%; low risk of hypoglycemia by CGM as defined by Dexcom Clarity report)
No episodes of severe hypoglycemia in the previous 3 months
Pump download shows regular meal bolusing, accurate carbohydrate counting ability, and willingness to use exercise markers in Dexcom
CGM download shows regular use (>85% of time) and regular calibration if using G5 sensor (G6 requires no calibration)
Females using adequate contraception

Exclusion Criteria

Use of CGM other than Dexcom G5 or G6 or a newer Dexcom CGM version
Suboptimal baseline glycemic control (HbA1c > 7.5%)
Pump or CGM download shows suboptimal use of devices (lack of meal boluses, frequent overrides of pump, excessive pump suspension, inadequate calibration or inconsistent usage of CGM)
Serious comorbidities including CVD with recent event, actively treated malignancy, renal dysfunction with eGFR < 45 ml/min, or any other condition which in the opinion of the investigator would preclude subject's ability to participate in trial
Females unwilling to use contraception, planning pregnancy or breastfeeding
Use of any other glucose-lowering agents than insulin
Hypersensitivity to insulin aspart or one of the excipients in faster insulin aspart
Known diabetic gastroparesis
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