- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977727
FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Texas
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Austin, Texas, United States, 78731
- Texas Diabetes & Endocrinology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening
- Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
- Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion
Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
Other Names:
CSII
Other Names:
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Experimental: 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
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Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
Other Names:
CSII
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-Hour Change in Postprandial Plasma Glucose (PPG)
Time Frame: 6th week of therapy
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Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test
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6th week of therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-Hour Change in Postprandial Plasma Glucose (PPG)
Time Frame: 6th week of therapy
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Change was calculated as the value at 2 hour minus the value at baseline during meal test
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6th week of therapy
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Percentage of Time Spent Between Below 70 mg/dL
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
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Weeks 1 through 6, Weeks 8 through 13
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Percentage of Time Spent Between 70 mg/dL and 180 mg/dL
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
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Weeks 1 through 6, Weeks 8 through 13
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Percentage of Time Spent Above 200 mg/dL
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
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Weeks 1 through 6, Weeks 8 through 13
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Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL)
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
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Weeks 1 through 6, Weeks 8 through 13
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Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL)
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
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Weeks 1 through 6, Weeks 8 through 13
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1,5 Anhydroglucitol Levels
Time Frame: Week 6, Week 13
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1,5 anhydroglucitol levels were measured on the 6th week of each therapy
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Week 6, Week 13
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Fructosamine Levels
Time Frame: Week 6, Week 13
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Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy
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Week 6, Week 13
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HbA1c
Time Frame: Week 6, Week 13
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Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy
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Week 6, Week 13
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Insulin Use - Change in Daily Dose
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period
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Weeks 1 through 6, Weeks 8 through 13
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Insulin Use - Bolus
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period
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Weeks 1 through 6, Weeks 8 through 13
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Insulin Use - Basal
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period
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Weeks 1 through 6, Weeks 8 through 13
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Insulin Use - Automatic Basal Insulin
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Average amount per day (units) calculated for each participant under each therapy
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Weeks 1 through 6, Weeks 8 through 13
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Insulin Pump - Active Insulin Time
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Average time per day (hours) calculated for each participant under each therapy
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Weeks 1 through 6, Weeks 8 through 13
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Insulin Pump - Auto Mode
Time Frame: Weeks 3 through 6, Weeks 10 through 13
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Percentage of time spent in auto-mode after calibration under each therapy
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Weeks 3 through 6, Weeks 10 through 13
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Insulin Pump - Manual Mode
Time Frame: Weeks 3 through 6, Weeks 10 through 13
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Percentage of time spent in manual-mode after calibration under each therapy
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Weeks 3 through 6, Weeks 10 through 13
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Change in Carbohydrate Ratio
Time Frame: Weeks 1 through 6, Weeks 8 through 13
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Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period
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Weeks 1 through 6, Weeks 8 through 13
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Infusion Site Reactions
Time Frame: 14 week treatment period
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Number of Infusion site reactions reported by patient
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14 week treatment period
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Pump Occlusions
Time Frame: 14 week treatment period
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Number of Occlusion events reported by patient
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14 week treatment period
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Collaborators and Investigators
Investigators
- Principal Investigator: Thomas Blevins, MD, Texas Diabetes & Endocrinology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1213-9104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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