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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2022
• Main ID: NCT02666430
• Date of registration: 25/01/2016
• Prospective Registration: No
• Primary sponsor: Mylan Inc.
• Public title: Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
• Scientific 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
• Date of first enrolment: December 2015
• Target sample size: 127
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02666430
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Czech Republic, Czechia, Estonia, Germany, Hungary, Latvia, Slovakia, United States

Contacts

• Name: Thomas Blevins
• Affiliation: Texas Diabetes & Endocrinology

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 66 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Drug: Lantus®

Drug: Mylan's insulin glargine

Primary Outcome(s)

Change in Hemoglobin A1c (HbA1c) From Baseline [Time Frame: Baseline to 36 weeks]

Secondary Outcome(s)

Change From Baseline Total Daily Insulin Dose [Time Frame: Baseline to 36 weeks]

Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay [Time Frame: Baseline to 36 weeks]

Hypoglycemic Rate [Time Frame: Baseline to 36 weeks]

Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay [Time Frame: Baseline to 36 weeks]

Hypoglycemic Incidence [Time Frame: Baseline to 36 weeks]

Local and Systemic Allergic Reactions [Time Frame: Baseline to 40 weeks]

Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline [Time Frame: Baseline to 36 weeks]

Change From Baseline in Total Insulin Antibodies - Lantus Assay [Time Frame: Baseline to 36 weeks]

Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay [Time Frame: Baseline to 36 weeks]

Change From Baseline in Fasting Plasma Glucose [Time Frame: Baseline to 36 weeks]

Secondary ID(s)

MYL-1501D-3003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mylan GmbH

Results

• Results available: Yes
• Date Posted: 14/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02666430