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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666430
• Other study ID #: MYL-1501D-3003
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: July 2017

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Mylan's insulin glargine

• Lantus®

Locations

Country	Name	City	State
Canada	Mylan Investigator Site	Laval	Quebec
Canada	Mylan Investigator Site	Montreal	Quebec
Canada	Mylan Investigator Site	Red Deer	Alberta
Canada	Mylan Investigator Site.	Vancouver	British Columbia
Canada	Mylan Investigator Site	Winnipeg	Manitoba
Czechia	Mylan Investigator Site	Brno Bohunice
Czechia	Mylan Investigator Site	Ceske Budejovice
Czechia	Mylan Investigator Site	Olomouc
Czechia	Mylan Investigator Site	Pardubice
Czechia	Mylan Investigator Site	Praha
Czechia	Mylan Investigator Site	Praha 10
Estonia	Mylan Investigator Site	Parnu
Estonia	Mylan Investigator Site	Tallinn
Estonia	Mylan Investigator Site	Tartu
Germany	Mylan Investigator Site	Aschaffenburg	Bayern
Germany	Mylan Investigator Site	Hamburg
Germany	Mylan Investigator Site	Hamburg
Germany	Mylan Investigator Site	Hohenmolsen	Sachsen Anhalt
Germany	Mylan Investigator Site	Munster	Nordrhein Westfalen
Hungary	Mylan Investigator Site	Budapest
Hungary	Mylan Investigator Site	Budapest
Hungary	Mylan Investigator Site	Eger
Hungary	Mylan Investigator Site	Letavertes
Hungary	Mylan Investigator Site	Miskolc
Hungary	Mylan Investigator Site	Szeged
Latvia	Mylan Investigator Site	Limbazi
Latvia	Mylan Investigator Site	Ogre
Latvia	Mylan Investigator Site	Riga
Latvia	Mylan Investigator Site	Riga
Latvia	Mylan Investigator Site	Sigulda
Latvia	Mylan Investigator Site	Talsi
Slovakia	Mylan Investigator Site	Bratislava
Slovakia	Mylan Investigator Site	Bratislava
Slovakia	Mylan Investigator Site	Dolny Kubin
Slovakia	Mylan Investigator Site	Levice
Slovakia	Mylan Investigator Site	Lubochna
Slovakia	Mylan Investigator Site	Nove Zamky
Slovakia	Mylan Investigator Site	Prievidza
Slovakia	Mylan Investigator Site	Rimavska Sobota
Slovakia	Mylan Investigator Site	Sturovo
Slovakia	Mylan Investigator Site	Trebisov
Slovakia	Mylan Investigator Site	Zilina
United States	Mylan Investigator Site	Albany	New York
United States	Mylan Investigator Site	Asheville	North Carolina
United States	Mylan Investigator Site	Atlanta	Georgia
United States	Mylan Investigator Site	Austin	Texas
United States	Mylan Investigator Site	Billings	Montana
United States	Mylan Investigator Site	Burlington	North Carolina
United States	Mylan Investigator Site	Chattanooga	Tennessee
United States	Mylan Investigator Site	Chesapeake	Virginia
United States	Mylan Investigator Site	Cincinnati	Ohio
United States	Mylan Investigator Site	Columbus	Georgia
United States	Mylan Investigator Site	Crystal Lake	Illinois
United States	Mylan Investigator Site	Dallas	Texas
United States	Mylan Investigator Site	Des Moines	Iowa
United States	Mylan Investigator Site	Fort Lauderdale	Florida
United States	Mylan Investigator Site	Fresno	California
United States	Mylan Investigator Site	Greenbrae	California
United States	Mylan Investigator Site	Greenville	North Carolina
United States	Mylan Investigator Site	Idaho Falls	Idaho
United States	Mylan Investigator Site	La Jolla	California
United States	Mylan Investigator Site	Lexington	Kentucky
United States	Mylan Investigator Site	Mentor	Ohio
United States	Mylan Investigator Site	Morehead City	North Carolina
United States	Mylan Investigator Site	New Port Richey	Florida
United States	Mylan Investigator Site	Northridge	California
United States	Mylan Investigator Site	Ogden	Utah
United States	Mylan Investigator Site	Omaha	Nebraska
United States	Mylan Investigator Site	Overland Park	Kansas
United States	Mylan Investigator Site	Palm Harbor	Florida
United States	Mylan Investigator Site	Renton	Washington
United States	Mylan Investigator Site	Salt Lake City	Utah
United States	Mylan Investigator Site	San Antonio	Texas
United States	Mylan Investigator Site	Springfield	Illinois
United States	Mylan Investigator Site	Staten Island	New York
United States	Mylan Investigator Site	Syracuse	New York
United States	Mylan Investigator Site	Tacoma	Washington
United States	Mylan Investigator Site	Tustin	California
United States	Mylan Investigator Site	Vancouver	Washington
United States	Mylan Investigator Site	West Palm Beach	Florida
United States	Mylan Investigator Site	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Mylan GmbH

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c (HbA1c) From Baseline		Baseline to 36 weeks
Secondary	Change From Baseline in Fasting Plasma Glucose		Baseline to 36 weeks
Secondary	Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline		Baseline to 36 weeks
Secondary	Change From Baseline Total Daily Insulin Dose		Baseline to 36 weeks
Secondary	Local and Systemic Allergic Reactions		Baseline to 40 weeks
Secondary	Hypoglycemic Rate		Baseline to 36 weeks
Secondary	Hypoglycemic Incidence		Baseline to 36 weeks
Secondary	Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay		Baseline to 36 weeks
Secondary	Change From Baseline in Total Insulin Antibodies - Lantus Assay		Baseline to 36 weeks
Secondary	Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay		Baseline to 36 weeks
Secondary	Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay		Baseline to 36 weeks