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

NCT04414579 | Unknown Phase 4 FDA Drug

• 1 other identifier: GPP2019
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

continuous glucose monitoring; continuous subcutaneous insulin infusion; hyperglycemia; correction bolus

Outcome Measures

Primary Outcomes (1)

• Time to stabilization of rising blood sugar by CGM after correction bolus

  Time (in minutes) to stabilization of rising blood sugar (GPP) by CGM after correction bolus during the final 2 week maintenance period. Two categories of correction dose will be analyzed: 1) those following an isolated correction dose (taken independently of a meal dose), and 2) those taken as part of a combination bolus with a meal dose.

  2 weeks

Secondary Outcomes (8)

• Incidence of early hypoglycemia

  25 weeks

• Change in Insulin Sensitivity Factor

  25 weeks

• Change in Insulin On Board

  25 weeks

• GlycoMark differences between arms

  25 weeks

• HbA1c differences between arms

  25 weeks

Study Arms (2)

No Intervention: Conventional Insulin Aspart (NovoLog®)

NO INTERVENTION

In the aspart group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Aspart is put into their pump and delivered to their body through a small tube placed under your skin. In this NovoLog®-only treatment group, the subject will take aspart with each meal while your pump also gives you a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study.

Faster Insulin Aspart (Fiasp®)

ACTIVE COMPARATOR

In the Fiasp group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Fiasp is put into their pump and delivered to their body through a small tube placed under their skin. In this Fiasp treatment group, the subject will take fiasp with each meal while their pump also gives them a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study.

Drug: Faster Insulin Aspart (Fiasp®)

Interventions

Faster Insulin Aspart (Fiasp®) DRUG

Subjects will be randomized either to use Fiasp or conventional insulin aspart in CSII. CSII settings (basal, bolus, and correction factors) will be optimized using a meal challenge for a 2-week run in period followed by a 10-week period of CSII use with the assigned insulin. After a 12-week maintenance period, each group will cross over to the other insulin (conventional insulin aspart or Fiasp) by CSII for a second 2-week optimization period followed by a 10-week treatment period.

Also known as: Conventional Insulin Aspart (NovoLog®)

Faster Insulin Aspart (Fiasp®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mountain Diabetes and Endocrine Center: lead

Study Sites (1)

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

RECRUITING

Related Publications (6)

• Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.

  PMID: 28055230 BACKGROUND

• Aleppo G, Laffel LM, Ahmann AJ, Hirsch IB, Kruger DF, Peters A, Weinstock RS, Harris DR. A Practical Approach to Using Trend Arrows on the Dexcom G5 CGM System for the Management of Adults With Diabetes. J Endocr Soc. 2017 Nov 20;1(12):1445-1460. doi: 10.1210/js.2017-00388. eCollection 2017 Dec 1.

  PMID: 29344577 BACKGROUND

• Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.

  PMID: 28205039 BACKGROUND

• Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C, Philis-Tsimikas A, Rose L, Woo VC, Osterskov AB, Graungaard T, Bergenstal RM. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017 Jul;40(7):943-950. doi: 10.2337/dc16-1771. Epub 2017 Mar 29.

  PMID: 28356319 BACKGROUND

• Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.

  PMID: 27629148 BACKGROUND

• Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.

  PMID: 30537180 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Wendy S Lane, MD

CONTACT

8286849588; mountaindiabetes@msn.com

Melinda L Buford, RN, BSN

CONTACT

8286849588; mbuford@mdecresearch.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label crossover trial. Subjects will be randomized to treatment sequence (Fiasp then NovoLog or NovoLog then Fiasp), each for a 12-week treatment period, by CSII. Randomization sequence will be determined by computerized randomization program. All patients will receive both treatments unless they drop out. Dropouts are unlikely since the participants are all regular continuing patients of the site's clinical practice.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wendy Lane, MD, Principal Investigator

Model Details: This is a 25-week open-label prospective single center 2 arm crossover trial consisting of a CSII settings (basal, bolus, and correction factors) will be optimized for a 2-week run in period followed by a 10-week period of CSII use with the assigned insulin. After a 12-week maintenance period, each group will cross over to the other insulin (conventional insulin aspart or Fiasp) by CSII for a second 2-week optimization period followed by a 10-week treatment period.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: March 27, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: post-study, up to 5 years
• Access Criteria: email Principal Investigator

Locations

US (1)