FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump

NCT03977727 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: U1111-1213-9104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 1-Hour Change in Postprandial Plasma Glucose (PPG)

  Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test

  6th week of therapy

Secondary Outcomes (19)

• 2-Hour Change in Postprandial Plasma Glucose (PPG)

  6th week of therapy

• Percentage of Time Spent Between Below 70 mg/dL

  Weeks 1 through 6, Weeks 8 through 13

• Percentage of Time Spent Between 70 mg/dL and 180 mg/dL

  Weeks 1 through 6, Weeks 8 through 13

• Percentage of Time Spent Above 200 mg/dL

  Weeks 1 through 6, Weeks 8 through 13

• Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)

  Weeks 1 through 6, Weeks 8 through 13

Study Arms (2)

Fiasp/Novolog

EXPERIMENTAL

7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion

Drug: Fiasp®; Drug: Novolog®; Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system

Novolog/Fiasp

EXPERIMENTAL

7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion

Drug: Fiasp®; Drug: Novolog®; Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system

Interventions

Fiasp® DRUG

Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system

Fiasp/Novolog; Novolog/Fiasp

Novolog® DRUG

Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system

Also known as: Aspart

Fiasp/Novolog; Novolog/Fiasp

670G hybrid closed loop continuous subcutaneous insulin infusion system DEVICE

CSII

Also known as: Medtronic 670G pump

Fiasp/Novolog; Novolog/Fiasp

Eligibility Criteria

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

You may qualify if:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male or female, age ≥18 years at the time of signing informed consent
• Documented diagnoses of T1DM ≥1 year prior to the day of screening
• Using the Medtronic pump Minimed 670G for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least 30 days prior to screening and willing to continue using their personal Medtronic Minimed 670G and CSII for insulin treatment throughout the trial.
• Ability and willingness to use the same insulin infusion sets throughout the trial
• Using the same insulin for at least 30 days prior to screening
• HbA1c \< 8.5% as assessed by local laboratory at screening
• BMI ≤ 35.0 kg/m2 at screening
• Ability and willingness to adhere to the protocol including performing SMPG profiles, attending visits, utilizing the auto mode feature of the pump for at least 80 % of the time during the study, and completing meal tests

You may not qualify if:

• Known or suspected hypersensitivity to trial products or related products
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
• Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
• Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
• Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening
• Subjects classified as being in New York Heart Association (NYHA) Class IV at screening
• Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
• Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic
• ≥180 mmHg or diastolic ≥110 mmHg) at screening
• Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \< 45 ml/min/1.73 m2
• Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator
• Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening
• History of hospitalization for ketoacidosis ≤180 days prior to the day of screening
• Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

Sponsors & Collaborators

• Texas Diabetes & Endocrinology, P.A.: lead

Study Sites (1)

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

Related Publications (1)

• Ozer K, Cooper AM, Ahn LP, Waggonner CR, Blevins TC. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021 Apr;23(4):286-292. doi: 10.1089/dia.2020.0500. Epub 2021 Mar 8.

  PMID: 33090016 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

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

Results Point of Contact

• Title: Thomas Blevins, MD
• Organization: Texas Diabetes & Endocrinology

blevins@texasdiabetes.com

512-334-3505

Study Officials

• Thomas Blevins, MD

  Texas Diabetes & Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: June 6, 2019
• Study Start: June 11, 2019
• Primary Completion: March 9, 2020
• Study Completion: April 20, 2020
• Last Updated: September 29, 2020
• Results First Posted: September 9, 2020

Record last verified: 2020-08

Locations

US (1)