Clinical trial NCT03977727: FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
Official title: An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Texas Diabetes & Endocrinology, P.A.
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

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
14. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening
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

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Primary outcomes:
measure: 1-Hour Change in Postprandial Plasma Glucose (PPG)
timeFrame: 6th week of therapy
Secondary outcomes:
measure: 2-Hour Change in Postprandial Plasma Glucose (PPG)
timeFrame: 6th week of therapy
measure: Percentage of Time Spent Between Below 70 mg/dL
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Percentage of Time Spent Between 70 mg/dL and 180 mg/dL
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Percentage of Time Spent Above 200 mg/dL
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: 1,5 Anhydroglucitol Levels
timeFrame: Week 6, Week 13
measure: Fructosamine Levels
timeFrame: Week 6, Week 13
measure: HbA1c
timeFrame: Week 6, Week 13
measure: Insulin Use - Change in Daily Dose
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Insulin Use - Bolus
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Insulin Use - Basal
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Insulin Use - Automatic Basal Insulin
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Insulin Pump - Active Insulin Time
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Insulin Pump - Auto Mode
timeFrame: Weeks 3 through 6, Weeks 10 through 13
measure: Insulin Pump - Manual Mode
timeFrame: Weeks 3 through 6, Weeks 10 through 13
measure: Change in Carbohydrate Ratio
timeFrame: Weeks 1 through 6, Weeks 8 through 13
measure: Infusion Site Reactions
timeFrame: 14 week treatment period
measure: Pump Occlusions
timeFrame: 14 week treatment period
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
Study officials:
affiliation: Texas Diabetes & Endocrinology
name: Thomas Blevins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.