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Mylan Insulin Aspart Study

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ClinicalTrials.gov Identifier: NCT03760068
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: MYL-1601D Product Drug: FlexPen NovoLog® Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 7, 2020
Estimated Study Completion Date : January 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: MYL-1601D Product (100 U/mL) Drug: MYL-1601D Product
(100 U/mL)

Active Comparator: FlexPen NovoLog® (100 U/mL) Drug: FlexPen NovoLog®
(100 U/mL)




Primary Outcome Measures :
  1. Antibody Response [ Time Frame: Baseline to week 24 ]
    The antibody response rate between the MYL-1601D and NovoLog® during 24 week treatment


Secondary Outcome Measures :
  1. Change in HbA1c from baseline [ Time Frame: Baseline to week 24 ]
  2. Change in fasting plasma glucose from baseline [ Time Frame: Baseline to week 24 ]
  3. Change in prandial insulin dose per unit body weight (U/kg) from baseline [ Time Frame: Baseline to week 24 ]
  4. Change in basal insulin dose per unit body weight (U/kg) from baseline [ Time Frame: Baseline to week 24 ]
  5. Change in total daily insulin dose per unit body weight (U/kg) from baseline [ Time Frame: Baseline to week 24 ]
  6. Change in 7-point SMBG profile from baseline [ Time Frame: Baseline to week 24 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Written and signed informed consent.
  2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
  3. Subject is able and willing to comply with the requirements of the study protocol.

Exclusion Criteria

  1. History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.
  2. History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
  3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
  4. Any elective surgery requiring hospitalization planned during the study period.
  5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
  6. Subjects with major depressive illness in the last 3 years.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760068


Contacts
Contact: Keri Vaughan +1 (267) 980-5015 keri.vaughan@mylan.com
Contact: Jessi Polis, MSN +1 (681) 209-0934 jessica.polis@mylan.com

Locations
United States, Texas
Clinical Trials of Texas, Inc Recruiting
San Antonio, Texas, United States, 78229
Contact: Lele Simmons    210-949-0122    lsimmons@cttexas.com   
Principal Investigator: Douglas Denham, DO         
Sponsors and Collaborators
Mylan Inc.
Mylan GmbH

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT03760068     History of Changes
Other Study ID Numbers: MYL-1601D-3001
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs