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

NCT ID: NCT03977727

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2020-04-20

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.

Detailed Description

This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.

Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fiasp/Novolog

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

Group Type: EXPERIMENTAL

Fiasp®

Intervention Type: DRUG

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

Novolog®

Intervention Type: DRUG

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

670G hybrid closed loop continuous subcutaneous insulin infusion system

Intervention Type: DEVICE

CSII

Novolog/Fiasp

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

Group Type: EXPERIMENTAL

Fiasp®

Intervention Type: DRUG

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

Novolog®

Intervention Type: DRUG

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

670G hybrid closed loop continuous subcutaneous insulin infusion system

Intervention Type: DEVICE

CSII

Interventions

Fiasp®

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

Intervention Type: DRUG

Novolog®

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

Intervention Type: DRUG

670G hybrid closed loop continuous subcutaneous insulin infusion system

CSII

Intervention Type: DEVICE

Other Intervention Names

Aspart; Medtronic 670G pump

Eligibility Criteria

Inclusion Criteria

1. 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

2. Male or female, age ≥18 years at the time of signing informed consent

3. Documented diagnoses of T1DM ≥1 year prior to the day of screening

4. 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.

5. Ability and willingness to use the same insulin infusion sets throughout the trial

6. Using the same insulin for at least 30 days prior to screening

7. HbA1c < 8.5% as assessed by local laboratory at screening

8. BMI ≤ 35.0 kg/m2 at screening

9. 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

15. Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

16. Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion

17. Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol

-

Exclusion Criteria

1. Known or suspected hypersensitivity to trial products or related products

2. 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)

3. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies

4. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial

5. 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

6. Subjects classified as being in New York Heart Association (NYHA) Class IV at screening

7. Planned coronary, carotid or peripheral artery revascularization known on the day of screening.

8. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic

≥180 mmHg or diastolic ≥110 mmHg) at screening

9. Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening

10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 ml/min/1.73 m2

11. 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

12. Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening

13. History of hospitalization for ketoacidosis ≤180 days prior to the day of screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Diabetes & Endocrinology, P.A.

OTHER

Sponsor Role: lead

Responsible Party

Thomas C. Blevins, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Blevins, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Diabetes & Endocrinology

Locations

Texas Diabetes & Endocrinology

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33090016 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U1111-1213-9104

Identifier Type: -

Identifier Source: org_study_id