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Trial record 3 of 13 for:    Mylan AND insulin

Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

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ClinicalTrials.gov Identifier: NCT02666430
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Mylan Inc.

Brief Summary:
The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Mylan's insulin glargine Drug: Lantus® Phase 3

Detailed Description:

This multi-center, open-label, randomized clinical extension study in patients with T1DM will assess safety and efficacy of Mylan's insulin glargine and Lantus®.

Patients with an established diagnosis of T1DM per American Diabetes Association 2014 criteria who were randomized to the Lantus® treatment arm of the Mylan Glargine 3001 study, and who have completed the 52-week treatment period on Lantus® will be eligible to be screened for the MYL-1501D-3003 study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multi-center, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients: An Extension Study
Actual Study Start Date : December 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Mylan's insulin glargine
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Drug: Mylan's insulin glargine
Active Comparator: Lantus®
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Drug: Lantus®



Primary Outcome Measures :
  1. Change in Hemoglobin A1c (HbA1c) From Baseline [ Time Frame: Baseline to 36 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline to 36 weeks ]
  2. Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline [ Time Frame: Baseline to 36 weeks ]
  3. Change From Baseline Total Daily Insulin Dose [ Time Frame: Baseline to 36 weeks ]
  4. Local and Systemic Allergic Reactions [ Time Frame: Baseline to 40 weeks ]
  5. Hypoglycemic Rate [ Time Frame: Baseline to 36 weeks ]
  6. Hypoglycemic Incidence [ Time Frame: Baseline to 36 weeks ]
  7. Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay [ Time Frame: Baseline to 36 weeks ]
  8. Change From Baseline in Total Insulin Antibodies - Lantus Assay [ Time Frame: Baseline to 36 weeks ]
  9. Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay [ Time Frame: Baseline to 36 weeks ]
  10. Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay [ Time Frame: Baseline to 36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study.
  2. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
  3. The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point self-monitoring blood glucose, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the extension study.
  4. Female patients complying with the following:

    • Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of randomization throughout the entire study.
    • Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study.
    • Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-GAI-3001 study.
    • All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES.
    • If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to inclusion in MYL-GAI-3001 study.

Exclusion Criteria:

  1. History or presence of a medical condition or disease that in the Investigator's opinion would place the patient at an unacceptable risk from trial participation.
  2. History of clinically significant (i.e., significant enough to alter the insulin dose requirement, as per the Investigator) acute bacterial, viral or fungal systemic infections in the 4 weeks prior to inclusion / randomization (recorded while collecting patient history) in to the MYL-1501D-3003 extension study
  3. Patients scheduled to receive another investigational drug during the extension study period
  4. Any major elective surgery requiring hospitalization planned during the extension study period.
  5. Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of ≥1.5 U/kg/day (Lantus® in U/kg/day or Mylan's insulin glargine in IU/kg/day).

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): NCT02666430


Locations
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Sponsors and Collaborators
Mylan Inc.
Mylan GmbH
Investigators
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Principal Investigator: Thomas Blevins Texas Diabetes & Endocrinology
  Study Documents (Full-Text)

Documents provided by Mylan Inc.:
Study Protocol  [PDF] May 6, 2016
Statistical Analysis Plan  [PDF] July 27, 2016

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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02666430    
Other Study ID Numbers: MYL-1501D-3003
First Posted: January 28, 2016    Key Record Dates
Results First Posted: September 14, 2020
Last Update Posted: September 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs