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

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ClinicalTrials.gov Identifier: NCT03977727
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.

Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Estimated Study Start Date  ICMJE June 4, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 1-hour plasma glucose levels on NovoLog [ Time Frame: 6th week of therapy ]
    Post-prandial 1-hour plasma glucose levels after 6 weeks of therapy on NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes.
  • 1-hour plasma glucose levels on Fiasp [ Time Frame: 6th week of therapy ]
    Post-prandial 1-hour plasma glucose levels after 6 weeks of therapy on Fiasp® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 2-hour plasma glucose levels on NovoLog [ Time Frame: 6th week of therapy ]
    Post-prandial 2-hour plasma glucose levels (m/dl) at 6 weeks after start of therapy with NovoLog®
  • 2-hour plasma glucose levels on Fiasp [ Time Frame: 6th week of therapy ]
    Post-prandial 2-hour plasma glucose levels (m/dl) at 6 weeks after start of therapy with Fiasp®
  • Glucose ranges [ Time Frame: Weeks 1 through 6, Weeks 8 through 13 ]
    Percent of time spent within the following ranges:
    • 70-180 mg/dl
    • < 70 mg/dl
    • > 200 mg/dl
    Percents are 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)
  • Glucose ranges [ Time Frame: 6 weeks with each drug ]
    Percent of time spent within the following conditions:
    • Hypoglycemia (mg/dl)
    • Severe hypoglycemia (mg/dl)
    Percents are calculated as the accumulated time in hours spent experiencing each condition divided by the total number of hours spent under therapy with each drug (6 weeks each)
  • Insulin use - Daily Dose [ Time Frame: 14 week treatment period ]
    - Total daily dose (units)
  • Insulin use - bolus/basal [ Time Frame: 14 week treatment period ]
    • change in %bolus insulin (units)
    • change in %basal insulin (units)
  • Insulin use - Automatic basal insulin [ Time Frame: 14 week treatment period ]
    Amount per day (units)
  • HbA1c [ Time Frame: 14 week treatment period ]
    - Measurement of cumulative glycemic control expressed in HbA1c%
  • 1,5 anhydroglucitol levels [ Time Frame: 20 weeks ]
    1,5 anhydroglucitol levels in mcg/ml prior to cross-over, and at end of study
  • fructosamine levels [ Time Frame: 14 week treatment period ]
    - Measurement of cumulative glycemic control expressed in fructosamine levels (micromol/Liter)
  • Insulin Pump - Active insulin time [ Time Frame: 14 week treatment period ]
    Active insulin time (hrs)
  • Insulin Pump - Mode [ Time Frame: 14 week treatment period ]
    • Time spent (%) in auto mode
    • Time spent (%) in manual mode
  • Carbohydrate ratio changes [ Time Frame: 14 week treatment period ]
    carbohydrate ratio from baseline to end of treatment ( I:CR)
  • Infusion Site reactions [ Time Frame: 14 week treatment period ]
    Number of Infusion site reactions reported by patient
  • Pump occlusions [ Time Frame: 14 week treatment period ]
    Number of Occlusion events reported by patient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Fiasp®
    Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
  • Drug: Novolog®
    Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
    Other Name: Aspart
  • Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system
    CSII
    Other Name: Medtronic 670G pump
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Fiasp®
    • Drug: Novolog®
    • Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system
  • 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
    Interventions:
    • Drug: Fiasp®
    • Drug: Novolog®
    • Device: 670G hybrid closed loop continuous subcutaneous insulin infusion system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alison Cooper, BS 512-334-3505 ext 1 acooper@texasdiabetes.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977727
Other Study ID Numbers  ICMJE U1111-1213-9104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.
Study Sponsor  ICMJE Texas Diabetes & Endocrinology, P.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Blevins, MD Texas Diabetes & Endocrinology
PRS Account Texas Diabetes & Endocrinology, P.A.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP