Mylan Insulin Aspart Study
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: MYL-1601D ProductDrug: FlexPen NovoLog®
- Registration Number
- NCT03760068
- Lead Sponsor
- Mylan Inc.
- Brief Summary
The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.
- Detailed Description
This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.
After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 478
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MYL-1601D Product (100 U/mL) MYL-1601D Product - FlexPen NovoLog® (100 U/mL) FlexPen NovoLog® -
- Primary Outcome Measures
Name Time Method Treatment Emergent Antibody Response (TEAR) Baseline to week 24 The number of subjects who were TEAR positive.
TEAR is defined as either one of the following:
1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline
2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
- Secondary Outcome Measures
Name Time Method Change in Prandial Insulin Dose From Baseline Baseline to week 24 Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Change in HbA1c From Baseline Baseline to week 24 Mean (SD) change from baseline HbA1c at Week 24.
Change in Fasting Plasma Glucose From Baseline Baseline to week 24 Mean (SD) change from baseline plasma glucose at Week 24.
Change in Total Daily Insulin Dose From Baseline Baseline to week 24 Mean (SD) change from baseline total daily insulin dose at Week 24
Change in Basal Insulin Dose From Baseline Baseline to week 24 Mean (SD) change from baseline total daily insulin dose at Week 24.
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline Baseline to week 24 Mean (SD) change in 7-point SMBG profile from baseline to Week 24
Related Research Topics
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Trial Locations
- Locations (151)
Endocrinology Associates Montgomery
🇺🇸Montgomery, Alabama, United States
Phoenician Centers for Research
🇺🇸Phoenix, Arizona, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
Medical Investigations Inc.
🇺🇸Little Rock, Arkansas, United States
John Muir Physician Network
🇺🇸Concord, California, United States
Valley Research
🇺🇸Fresno, California, United States
Marin Endocrine Care & Research, Inc.
🇺🇸Greenbrae, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, United States
Diabetes And Endocrine Associates
🇺🇸La Mesa, California, United States
Long Beach Center For Clinical Research
🇺🇸Long Beach, California, United States
Scroll for more (141 remaining)Endocrinology Associates Montgomery🇺🇸Montgomery, Alabama, United States