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NCT02227862 Clinical Trial

Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02227862
Other study ID # MYL-GAI-3001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2014
Est. completion date July 2016

Study information
Verified date March 2022
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility
Status Completed
Enrollment 558
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mylan's insulin glargine
All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
• Lantus®
All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.

Locations
Country Name City State
Canada Mylan Investigational Site Laval Quebec
Canada Mylan Investigational Site Mirabel Quebec
Canada Mylan Investigational Site Montreal Quebec
Canada Mylan Investigational Site Red Deer Alberta
Canada Mylan Investigational Site Vancouver British Columbia
Canada Mylan Investigational Site Winnipeg Manitoba
Czechia Mylan Investigational Site Brno
Czechia Mylan Investigational Site Brno
Czechia Mylan Investigational Site Broumov
Czechia Mylan Investigational Site Bruntal
Czechia Mylan Investigational Site Ceske Budejovice
Czechia Mylan Investigational Site Olomouc
Czechia Mylan Investigational Site Pardubice
Czechia Mylan Investigational Site Praha 10
Czechia Mylan Investigational Site Praha 10
Estonia Mylan Investigational Site Parnu
Estonia Mylan Investigational Site Tallinn
Estonia Mylan Investigational Site Tartu
Germany Mylan Investigational Site Aschaffenburg Bayern
Germany Mylan Investigational Site Dresden Sachsen
Germany Mylan Investigational Site Frankfurt Hessen
Germany Mylan Investigational Site Hamburg
Germany Mylan Investigational Site Hamburg
Germany Mylan Investigational Site Hohenmölsen Anhalt
Germany Mylan Investigational Site Muenster Nordrhein Westfalen
Germany Mylan Investigational Site Sankt Ingbert Saarland
Germany Mylan Investigational Site Schweinfurt Bayern
Germany Mylan Investigational Site Wangen im Allgau Baden Wuerttemberg
Hungary Mylan Investigational Site Baja
Hungary Mylan Investigational Site Budapest
Hungary Mylan Investigational Site Budapest
Hungary Mylan Investigational Site Budapest
Hungary Mylan Investigational Site Eger
Hungary Mylan Investigational Site Gyula
Hungary Mylan Investigational Site Letavertes
Hungary Mylan Investigational Site Mako
Hungary Mylan Investigational Site Miskolc
Hungary Mylan Investigational Site Szeged
Latvia Mylan Investigational Site Kuldiga
Latvia Mylan Investigational Site Limbazi
Latvia Mylan Investigational Site Ogre
Latvia Mylan Investigational Site Riga
Latvia Mylan Investigational Site Riga
Latvia Mylan Investigational Site Riga
Latvia Mylan Investigational Site Sigulda
Latvia Mylan Investigational Site Talsi
Romania Mylan Investigational Site Bacau
Romania Mylan Investigational Site Baia Mare
Romania Mylan Investigational Site Bucuresti
Romania Mylan Investigational Site Bucuresti
Romania Mylan Investigational Site Buzau
Romania Mylan Investigational Site Cluj Napoca
Romania Mylan Investigational Site Galati
Romania Mylan Investigational Site Iasi
Romania Mylan Investigational Site Oradea
Romania Mylan Investigational Site Oradea
Romania Mylan Investigational Site Timisoara
Slovakia Mylan Investigational Site Banska Bystrica
Slovakia Mylan Investigational Site Bardejov
Slovakia Mylan Investigational Site Bratislava
Slovakia Mylan Investigational Site Bratislava
Slovakia Mylan Investigational Site Bratislava
Slovakia Mylan Investigational Site Dolny Kubin
Slovakia Mylan Investigational Site Kosice
Slovakia Mylan Investigational Site Levice
Slovakia Mylan Investigational Site Lubochna
Slovakia Mylan Investigational Site Nove Mesto nad Vahom
Slovakia Mylan Investigational Site Nove Zamky
Slovakia Mylan Investigational Site Presov
Slovakia Mylan Investigational Site Prievidza
Slovakia Mylan Investigational Site Pruske
Slovakia Mylan Investigational Site Rimavska Sobota
Slovakia Mylan Investigational Site Sabinov
Slovakia Mylan Investigational Site Skalica
Slovakia Mylan Investigational Site Sturovo
Slovakia Mylan Investigational Site Trebisov
Slovakia Mylan Investigational Site Zilina
South Africa Mylan Investigational Site Bloemfontein Free State
South Africa Mylan Investigational Site Cape Town Western Cape
South Africa Mylan Investigational Site Cape Town Western Cape
South Africa Mylan Investigational Site Cape Town Western Cape
South Africa Mylan Investigational Site Durban KwaZulu-Natal
South Africa Mylan Investigational Site Johannesburg Gauteng
South Africa Mylan Investigational Site Johannesburg Gauteng
South Africa Mylan Investigational Site Johannesburg Gauteng
South Africa Mylan Investigational Site Krugersdorp Gauteng
South Africa Mylan Investigational Site Pretoria Gauteng
United Kingdom Mylan Investigational Site Leicester Leicestershire
United Kingdom Mylan Investigational Site Plymouth Devon
United Kingdom Mylan Investigational Site Swansea
United States Mylan Investigational Site Albany New York
United States Mylan Investigational Site Anderson Indiana
United States Mylan Investigational Site Asheville North Carolina
United States Mylan Investigational Site Atlanta Georgia
United States Mylan Investigational Site Austin Texas
United States Mylan Investigational Site Bell Gardens California
United States Mylan Investigational Site Bend Oregon
United States Mylan Investigational Site Billings Montana
United States Mylan Investigational Site Bradenton Florida
United States Mylan Investigational Site Burlington North Carolina
United States Mylan Investigational Site Chattanooga Tennessee
United States Mylan Investigational Site Chesapeake Virginia
United States Mylan Investigational Site Cincinnati Ohio
United States Mylan Investigational Site Columbus Georgia
United States Mylan Investigational Site Cooper City Florida
United States Mylan Investigational Site Corvallis Oregon
United States Mylan Investigational Site Council Bluffs Iowa
United States Mylan Investigational Site Crystal Lake Illinois
United States Mylan Investigational Site Dallas Texas
United States Mylan Investigational Site Des Moines Iowa
United States Mylan Investigational Site El Paso Texas
United States Mylan Investigational Site Fresno California
United States Mylan Investigational Site Greenbrae California
United States Mylan Investigational Site Greensboro North Carolina
United States Mylan Investigational Site Greenville North Carolina
United States Mylan Investigational Site Hialeah Florida
United States Mylan Investigational Site Hickory North Carolina
United States Mylan Investigational Site Hollywood Florida
United States Mylan Investigational Site Honolulu Hawaii
United States Mylan Investigational Site Idaho Falls Idaho
United States Mylan Investigational Site La Jolla California
United States Mylan Investigational Site La Mesa California
United States Mylan Investigational Site LaGrange Illinois
United States Mylan Investigational Site Las Vegas Nevada
United States Mylan Investigational Site Lexington Kentucky
United States Mylan Investigational Site Long Beach California
United States Mylan Investigational Site Los Gatos California
United States Mylan Investigational Site Manassas Virginia
United States Mylan Investigational Site Memphis Tennessee
United States Mylan Investigational Site Mentor Ohio
United States Mylan Investigational Site Miami Florida
United States Mylan Investigational Site Miami Florida
United States Mylan Investigational Site Mineola New York
United States Mylan Investigational Site Mission Hills California
United States Mylan Investigational Site Morehead City North Carolina
United States Mylan Investigational Site Muncie Indiana
United States Mylan Investigational Site National City California
United States Mylan Investigational Site New Port Richey Florida
United States Mylan Investigational Site Northridge California
United States Mylan Investigational Site Ogden Utah
United States Mylan Investigational Site Omaha Nebraska
United States Mylan Investigational Site Omaha Nebraska
United States Mylan Investigational Site Overland Park Kansas
United States Mylan Investigational Site Palm Harbor Florida
United States Mylan Investigational Site Renton Washington
United States Mylan Investigational Site Round Rock Texas
United States Texas Diabetes & Endocrinology Round Rock Texas
United States Mylan Investigational Site Salt Lake City Utah
United States Mylan Investigational Site Salt Lake City Utah
United States Mylan Investigational Site Salt Lake City Utah
United States Mylan Investigational Site San Antonio Texas
United States Mylan Investigational Site South Jordan Utah
United States Mylan Investigational Site Springfield Illinois
United States Mylan Investigational Site Staten Island New York
United States Mylan Investigational Site Syracuse New York
United States Mylan Investigational Site Tacoma Washington
United States Mylan Investigational Site Topeka Kansas
United States Mylan Investigational Site Tustin California
United States Mylan Investigational Site Vancouver Washington
United States Mylan Investigational Site Walnut Creek California
United States Mylan Investigational Site West Palm Beach Florida
United States Mylan Investigational 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,  Romania,  Slovakia,  South Africa,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c From Baseline to 24 Weeks 24 weeks
Secondary Summary of Actual and Change From Baseline in HbA1c 24 and 52 weeks
Secondary Change From Baseline in FPG Over Time 24 and 52 weeks
Secondary Change From Baseline in 8-point SMBG Profile Over Time 24 and 52 weeks
Secondary Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time 24 and 52 weeks
Secondary Rate of Hypoglycemic Events Per 30 Days Over Time 24 and 52 weeks
Secondary Hypoglycemia Occurrence 52 weeks
Secondary Occurrence of Local and Systematic Reactions 52 weeks
Secondary Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time 24 and 52 weeks
Secondary Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time 24 and 52 weeks
Secondary Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time 24 and 52 weeks
Secondary Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time 24 and 52 weeks
Secondary Proportion of Patients With HbA1c < 7% 24 and 52 weeks
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