Clinical trial NCT02666430: Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan GmbH
First posted: 2016-01-28
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) From Baseline
timeFrame: Baseline to 36 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: Baseline to 36 weeks
measure: Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline
timeFrame: Baseline to 36 weeks
measure: Change From Baseline Total Daily Insulin Dose
timeFrame: Baseline to 36 weeks
measure: Local and Systemic Allergic Reactions
timeFrame: Baseline to 40 weeks
measure: Hypoglycemic Rate
timeFrame: Baseline to 36 weeks
measure: Hypoglycemic Incidence
timeFrame: Baseline to 36 weeks
measure: Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay
timeFrame: Baseline to 36 weeks
measure: Change From Baseline in Total Insulin Antibodies - Lantus Assay
timeFrame: Baseline to 36 weeks
measure: Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay
timeFrame: Baseline to 36 weeks
measure: Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay
timeFrame: Baseline to 36 weeks
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Mylan Investigator Site
state: California
city: Greenbrae
country: United States
facility: Mylan Investigator Site
state: California
city: La Jolla
country: United States
facility: Mylan Investigator Site
state: California
city: Northridge
country: United States
facility: Mylan Investigator Site
state: California
city: Tustin
country: United States
facility: Mylan Investigator Site
state: California
city: Fort Lauderdale
country: United States
facility: Mylan Investigator Site
state: Florida
city: New Port Richey
country: United States
facility: Mylan Investigator Site
state: Florida
city: Palm Harbor
country: United States
facility: Mylan Investigator Site
state: Florida
city: West Palm Beach
country: United States
facility: Mylan Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Mylan Investigator Site
state: Georgia
city: Columbus
country: United States
facility: Mylan Investigator Site
state: Georgia
city: Idaho Falls
country: United States
facility: Mylan Investigator Site
state: Idaho
city: Crystal Lake
country: United States
facility: Mylan Investigator Site
state: Illinois
city: Springfield
country: United States
facility: Mylan Investigator Site
state: Illinois
city: Des Moines
country: United States
facility: Mylan Investigator Site
state: Iowa
city: Overland Park
country: United States
facility: Mylan Investigator Site
state: Kansas
city: Lexington
country: United States
facility: Mylan Investigator Site
state: Kentucky
city: Billings
country: United States
facility: Mylan Investigator Site
state: Montana
city: Omaha
country: United States
facility: Mylan Investigator Site
state: Nebraska
city: Albany
country: United States
facility: Mylan Investigator Site
state: New York
city: Staten Island
country: United States
facility: Mylan Investigator Site
state: New York
city: Syracuse
country: United States
facility: Mylan Investigator Site
state: New York
city: Asheville
country: United States
facility: Mylan Investigator Site
state: North Carolina
city: Burlington
country: United States
facility: Mylan Investigator Site
state: North Carolina
city: Greenville
country: United States
facility: Mylan Investigator Site
state: North Carolina
city: Morehead City
country: United States
facility: Mylan Investigator Site
state: North Carolina
city: Wilmington
country: United States
facility: Mylan Investigator Site
state: North Carolina
city: Cincinnati
country: United States
facility: Mylan Investigator Site
state: Ohio
city: Mentor
country: United States
facility: Mylan Investigator Site
state: Ohio
city: Chattanooga
country: United States
facility: Mylan Investigator Site
state: Tennessee
city: Austin
country: United States
facility: Mylan Investigator Site
state: Texas
city: Dallas
country: United States
facility: Mylan Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Mylan Investigator Site
state: Texas
city: Ogden
country: United States
facility: Mylan Investigator Site
state: Utah
city: Salt Lake City
country: United States
facility: Mylan Investigator Site
state: Utah
city: Chesapeake
country: United States
facility: Mylan Investigator Site
state: Virginia
city: Renton
country: United States
facility: Mylan Investigator Site
state: Washington
city: Tacoma
country: United States
facility: Mylan Investigator Site
state: Washington
city: Vancouver
country: United States
facility: Mylan Investigator Site
state: Washington
city: Red Deer
country: Canada
facility: Mylan Investigator Site
state: Alberta
city: Vancouver
country: Canada
facility: Mylan Investigator Site.
state: British Columbia
city: Winnipeg
country: Canada
facility: Mylan Investigator Site
state: Manitoba
city: Laval
country: Canada
facility: Mylan Investigator Site
state: Quebec
city: Montreal
country: Canada
facility: Mylan Investigator Site
state: Quebec
city: Brno Bohunice
country: Czechia
facility: Mylan Investigator Site
city: Ceske Budejovice
country: Czechia
facility: Mylan Investigator Site
city: Olomouc
country: Czechia
facility: Mylan Investigator Site
city: Pardubice
country: Czechia
facility: Mylan Investigator Site
city: Praha 10
country: Czechia
facility: Mylan Investigator Site
city: Praha
country: Czechia
facility: Mylan Investigator Site
city: Parnu
country: Estonia
facility: Mylan Investigator Site
city: Tallinn
country: Estonia
facility: Mylan Investigator Site
city: Tartu
country: Estonia
facility: Mylan Investigator Site
city: Aschaffenburg
country: Germany
facility: Mylan Investigator Site
state: Bayern
city: Munster
country: Germany
facility: Mylan Investigator Site
state: Nordrhein Westfalen
city: Hohenmolsen
country: Germany
facility: Mylan Investigator Site
state: Sachsen Anhalt
city: Hamburg
country: Germany
facility: Mylan Investigator Site
city: Hamburg
country: Germany
facility: Mylan Investigator Site
city: Budapest
country: Hungary
facility: Mylan Investigator Site
city: Budapest
country: Hungary
facility: Mylan Investigator Site
city: Eger
country: Hungary
facility: Mylan Investigator Site
city: Letavertes
country: Hungary
facility: Mylan Investigator Site
city: Miskolc
country: Hungary
facility: Mylan Investigator Site
city: Szeged
country: Hungary
facility: Mylan Investigator Site
city: Limbazi
country: Latvia
facility: Mylan Investigator Site
city: Ogre
country: Latvia
facility: Mylan Investigator Site
city: Riga
country: Latvia
facility: Mylan Investigator Site
city: Riga
country: Latvia
facility: Mylan Investigator Site
city: Sigulda
country: Latvia
facility: Mylan Investigator Site
city: Talsi
country: Latvia
facility: Mylan Investigator Site
city: Bratislava
country: Slovakia
facility: Mylan Investigator Site
city: Bratislava
country: Slovakia
facility: Mylan Investigator Site
city: Dolny Kubin
country: Slovakia
facility: Mylan Investigator Site
city: Levice
country: Slovakia
facility: Mylan Investigator Site
city: Lubochna
country: Slovakia
facility: Mylan Investigator Site
city: Nove Zamky
country: Slovakia
facility: Mylan Investigator Site
city: Prievidza
country: Slovakia
facility: Mylan Investigator Site
city: Rimavska Sobota
country: Slovakia
facility: Mylan Investigator Site
city: Sturovo
country: Slovakia
facility: Mylan Investigator Site
city: Trebisov
country: Slovakia
facility: Mylan Investigator Site
city: Zilina
country: Slovakia
facility: Mylan Investigator Site
Study officials:
affiliation: Texas Diabetes & Endocrinology
name: Thomas Blevins
role: PRINCIPAL_INVESTIGATOR
References: