Clinical trial NCT02227862: Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan GmbH
First posted: 2014-08-28
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.

Detailed description: This trial is a multicenter, open-label, randomized, parallel-group trial in patients with Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.

Eligibility criteria: Inclusion Criteria:

* Patients with an established diagnosis of T1DM per ADA 2014 criteria
* Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
* Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.
* Hemoglobin ≥9.0 g/dL at screening.

Exclusion Criteria:

* History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
* History of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
* History of use of a regular immunomodulator therapy in the 1 year prior to screening.
* History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I), as judged by the investigator.
* History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
* Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.
* History of drug or alcohol dependence or abuse during the 1 year prior to screening.

Primary outcomes:
measure: Change in HbA1c From Baseline to 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Summary of Actual and Change From Baseline in HbA1c
timeFrame: 24 and 52 weeks
measure: Change From Baseline in FPG Over Time
timeFrame: 24 and 52 weeks
measure: Change From Baseline in 8-point SMBG Profile Over Time
timeFrame: 24 and 52 weeks
measure: Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time
timeFrame: 24 and 52 weeks
measure: Rate of Hypoglycemic Events Per 30 Days Over Time
timeFrame: 24 and 52 weeks
measure: Hypoglycemia Occurrence
timeFrame: 52 weeks
measure: Occurrence of Local and Systematic Reactions
timeFrame: 52 weeks
measure: Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
timeFrame: 24 and 52 weeks
measure: Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
timeFrame: 24 and 52 weeks
measure: Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
timeFrame: 24 and 52 weeks
measure: Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
timeFrame: 24 and 52 weeks
measure: Proportion of Patients With HbA1c < 7%
timeFrame: 24 and 52 weeks
Other outcomes:
Locations:
city: Bell Gardens
country: United States
facility: Mylan Investigational Site
state: California
city: Fresno
country: United States
facility: Mylan Investigational Site
state: California
city: Greenbrae
country: United States
facility: Mylan Investigational Site
state: California
city: La Jolla
country: United States
facility: Mylan Investigational Site
state: California
city: La Mesa
country: United States
facility: Mylan Investigational Site
state: California
city: Long Beach
country: United States
facility: Mylan Investigational Site
state: California
city: Los Gatos
country: United States
facility: Mylan Investigational Site
state: California
city: Mission Hills
country: United States
facility: Mylan Investigational Site
state: California
city: National City
country: United States
facility: Mylan Investigational Site
state: California
city: Northridge
country: United States
facility: Mylan Investigational Site
state: California
city: Tustin
country: United States
facility: Mylan Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Mylan Investigational Site
state: California
city: Bradenton
country: United States
facility: Mylan Investigational Site
state: Florida
city: Cooper City
country: United States
facility: Mylan Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Mylan Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Mylan Investigational Site
state: Florida
city: Miami
country: United States
facility: Mylan Investigational Site
state: Florida
city: Miami
country: United States
facility: Mylan Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Mylan Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Mylan Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Mylan Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Mylan Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Mylan Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Mylan Investigational Site
state: Hawaii
city: Idaho Falls
country: United States
facility: Mylan Investigational Site
state: Idaho
city: Crystal Lake
country: United States
facility: Mylan Investigational Site
state: Illinois
city: LaGrange
country: United States
facility: Mylan Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Mylan Investigational Site
state: Illinois
city: Anderson
country: United States
facility: Mylan Investigational Site
state: Indiana
city: Muncie
country: United States
facility: Mylan Investigational Site
state: Indiana
city: Council Bluffs
country: United States
facility: Mylan Investigational Site
state: Iowa
city: Des Moines
country: United States
facility: Mylan Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: Mylan Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Mylan Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Mylan Investigational Site
state: Kentucky
city: Billings
country: United States
facility: Mylan Investigational Site
state: Montana
city: Omaha
country: United States
facility: Mylan Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Mylan Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Mylan Investigational Site
state: Nevada
city: Albany
country: United States
facility: Mylan Investigational Site
state: New York
city: Mineola
country: United States
facility: Mylan Investigational Site
state: New York
city: Staten Island
country: United States
facility: Mylan Investigational Site
state: New York
city: Syracuse
country: United States
facility: Mylan Investigational Site
state: New York
city: Asheville
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Burlington
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Mylan Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Mylan Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Mylan Investigational Site
state: Ohio
city: Bend
country: United States
facility: Mylan Investigational Site
state: Oregon
city: Corvallis
country: United States
facility: Mylan Investigational Site
state: Oregon
city: Chattanooga
country: United States
facility: Mylan Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Mylan Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Mylan Investigational Site
state: Texas
city: Dallas
country: United States
facility: Mylan Investigational Site
state: Texas
city: El Paso
country: United States
facility: Mylan Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Mylan Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Mylan Investigational Site
state: Texas
city: Ogden
country: United States
facility: Mylan Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Mylan Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Mylan Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Mylan Investigational Site
state: Utah
city: South Jordan
country: United States
facility: Mylan Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Mylan Investigational Site
state: Virginia
city: Manassas
country: United States
facility: Mylan Investigational Site
state: Virginia
city: Renton
country: United States
facility: Mylan Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Mylan Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Mylan Investigational Site
state: Washington
city: Red Deer
country: Canada
facility: Mylan Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Mylan Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Mylan Investigational Site
state: Manitoba
city: Laval
country: Canada
facility: Mylan Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: Mylan Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Mylan Investigational Site
state: Quebec
city: Brno
country: Czechia
facility: Mylan Investigational Site
city: Brno
country: Czechia
facility: Mylan Investigational Site
city: Broumov
country: Czechia
facility: Mylan Investigational Site
city: Bruntal
country: Czechia
facility: Mylan Investigational Site
city: Ceske Budejovice
country: Czechia
facility: Mylan Investigational Site
city: Olomouc
country: Czechia
facility: Mylan Investigational Site
city: Pardubice
country: Czechia
facility: Mylan Investigational Site
city: Praha 10
country: Czechia
facility: Mylan Investigational Site
city: Praha 10
country: Czechia
facility: Mylan Investigational Site
city: Parnu
country: Estonia
facility: Mylan Investigational Site
city: Tallinn
country: Estonia
facility: Mylan Investigational Site
city: Tartu
country: Estonia
facility: Mylan Investigational Site
city: Hohenmölsen
country: Germany
facility: Mylan Investigational Site
state: Anhalt
city: Wangen im Allgau
country: Germany
facility: Mylan Investigational Site
state: Baden Wuerttemberg
city: Aschaffenburg
country: Germany
facility: Mylan Investigational Site
state: Bayern
city: Schweinfurt
country: Germany
facility: Mylan Investigational Site
state: Bayern
city: Frankfurt
country: Germany
facility: Mylan Investigational Site
state: Hessen
city: Muenster
country: Germany
facility: Mylan Investigational Site
state: Nordrhein Westfalen
city: Sankt Ingbert
country: Germany
facility: Mylan Investigational Site
state: Saarland
city: Dresden
country: Germany
facility: Mylan Investigational Site
state: Sachsen
city: Hamburg
country: Germany
facility: Mylan Investigational Site
city: Hamburg
country: Germany
facility: Mylan Investigational Site
city: Baja
country: Hungary
facility: Mylan Investigational Site
city: Budapest
country: Hungary
facility: Mylan Investigational Site
city: Budapest
country: Hungary
facility: Mylan Investigational Site
city: Budapest
country: Hungary
facility: Mylan Investigational Site
city: Eger
country: Hungary
facility: Mylan Investigational Site
city: Gyula
country: Hungary
facility: Mylan Investigational Site
city: Letavertes
country: Hungary
facility: Mylan Investigational Site
city: Mako
country: Hungary
facility: Mylan Investigational Site
city: Miskolc
country: Hungary
facility: Mylan Investigational Site
city: Szeged
country: Hungary
facility: Mylan Investigational Site
city: Kuldiga
country: Latvia
facility: Mylan Investigational Site
city: Limbazi
country: Latvia
facility: Mylan Investigational Site
city: Ogre
country: Latvia
facility: Mylan Investigational Site
city: Riga
country: Latvia
facility: Mylan Investigational Site
city: Riga
country: Latvia
facility: Mylan Investigational Site
city: Riga
country: Latvia
facility: Mylan Investigational Site
city: Sigulda
country: Latvia
facility: Mylan Investigational Site
city: Talsi
country: Latvia
facility: Mylan Investigational Site
city: Bacau
country: Romania
facility: Mylan Investigational Site
city: Baia Mare
country: Romania
facility: Mylan Investigational Site
city: Bucuresti
country: Romania
facility: Mylan Investigational Site
city: Bucuresti
country: Romania
facility: Mylan Investigational Site
city: Buzau
country: Romania
facility: Mylan Investigational Site
city: Cluj Napoca
country: Romania
facility: Mylan Investigational Site
city: Galati
country: Romania
facility: Mylan Investigational Site
city: Iasi
country: Romania
facility: Mylan Investigational Site
city: Oradea
country: Romania
facility: Mylan Investigational Site
city: Oradea
country: Romania
facility: Mylan Investigational Site
city: Timisoara
country: Romania
facility: Mylan Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Mylan Investigational Site
city: Bardejov
country: Slovakia
facility: Mylan Investigational Site
city: Bratislava
country: Slovakia
facility: Mylan Investigational Site
city: Bratislava
country: Slovakia
facility: Mylan Investigational Site
city: Bratislava
country: Slovakia
facility: Mylan Investigational Site
city: Dolny Kubin
country: Slovakia
facility: Mylan Investigational Site
city: Kosice
country: Slovakia
facility: Mylan Investigational Site
city: Levice
country: Slovakia
facility: Mylan Investigational Site
city: Lubochna
country: Slovakia
facility: Mylan Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: Mylan Investigational Site
city: Nove Zamky
country: Slovakia
facility: Mylan Investigational Site
city: Presov
country: Slovakia
facility: Mylan Investigational Site
city: Prievidza
country: Slovakia
facility: Mylan Investigational Site
city: Pruske
country: Slovakia
facility: Mylan Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: Mylan Investigational Site
city: Sabinov
country: Slovakia
facility: Mylan Investigational Site
city: Skalica
country: Slovakia
facility: Mylan Investigational Site
city: Sturovo
country: Slovakia
facility: Mylan Investigational Site
city: Trebisov
country: Slovakia
facility: Mylan Investigational Site
city: Zilina
country: Slovakia
facility: Mylan Investigational Site
city: Bloemfontein
country: South Africa
facility: Mylan Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Mylan Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Mylan Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Mylan Investigational Site
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Mylan Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Mylan Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Mylan Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Mylan Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Mylan Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Mylan Investigational Site
state: Western Cape
city: Plymouth
country: United Kingdom
facility: Mylan Investigational Site
state: Devon
city: Leicester
country: United Kingdom
facility: Mylan Investigational Site
state: Leicestershire
city: Swansea
country: United Kingdom
facility: Mylan Investigational Site
Study officials:
affiliation: Texas Diabetes & Endocrinology
name: Thomas Blevins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy AS, Ramaswamy S, Pathak D, Bowsher RR, Raiter Y, Aubonnet P, Barve A. Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies. BMC Endocr Disord. 2021 Jun 26;21(1):129. doi: 10.1186/s12902-021-00797-4.