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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mylan's insulin glargine
Lantus®
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Texas Diabetes & Endocrinology
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
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  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
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  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site
  • Mylan Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mylan's Insulin Glargine

Lantus®

Arm Description

Receive Mylan's Insulin Glargine plus insulin lispro.

Receive Lantus® plus insulin lispro

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to 24 Weeks

Secondary Outcome Measures

Summary of Actual and Change From Baseline in HbA1c
Change From Baseline in FPG Over Time
Change From Baseline in 8-point SMBG Profile Over Time
Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time
Rate of Hypoglycemic Events Per 30 Days Over Time
Hypoglycemia Occurrence
Occurrence of Local and Systematic Reactions
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Proportion of Patients With HbA1c < 7%

Full Information

First Posted
August 26, 2014
Last Updated
March 1, 2022
Sponsor
Mylan Inc.
Collaborators
Mylan GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02227862
Brief Title
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Acronym
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
Mylan GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mylan's Insulin Glargine
Arm Type
Experimental
Arm Description
Receive Mylan's Insulin Glargine plus insulin lispro.
Arm Title
Lantus®
Arm Type
Active Comparator
Arm Description
Receive Lantus® plus insulin lispro
Intervention Type
Drug
Intervention Name(s)
Mylan's insulin glargine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lantus®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to 24 Weeks
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Summary of Actual and Change From Baseline in HbA1c
Time Frame
24 and 52 weeks
Title
Change From Baseline in FPG Over Time
Time Frame
24 and 52 weeks
Title
Change From Baseline in 8-point SMBG Profile Over Time
Time Frame
24 and 52 weeks
Title
Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time
Time Frame
24 and 52 weeks
Title
Rate of Hypoglycemic Events Per 30 Days Over Time
Time Frame
24 and 52 weeks
Title
Hypoglycemia Occurrence
Time Frame
52 weeks
Title
Occurrence of Local and Systematic Reactions
Time Frame
52 weeks
Title
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Time Frame
24 and 52 weeks
Title
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Time Frame
24 and 52 weeks
Title
Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Time Frame
24 and 52 weeks
Title
Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Time Frame
24 and 52 weeks
Title
Proportion of Patients With HbA1c < 7%
Time Frame
24 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Blevins, MD
Organizational Affiliation
Texas Diabetes & Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mylan Investigational Site
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Mylan Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Mylan Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Mylan Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Mylan Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Mylan Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Mylan Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Mylan Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Mylan Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Mylan Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Mylan Investigational Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Mylan Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Mylan Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Mylan Investigational Site
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Mylan Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Mylan Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mylan Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Mylan Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Mylan Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Mylan Investigational Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Mylan Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Mylan Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Mylan Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Mylan Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Mylan Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Mylan Investigational Site
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Mylan Investigational Site
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Mylan Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Mylan Investigational Site
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Mylan Investigational Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Mylan Investigational Site
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Mylan Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mylan Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Mylan Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Mylan Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Mylan Investigational Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Mylan Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Mylan Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Mylan Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Mylan Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Mylan Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mylan Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Mylan Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Mylan Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Mylan Investigational Site
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Mylan Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Mylan Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Mylan Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Mylan Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Mylan Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Mylan Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Mylan Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Mylan Investigational Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Mylan Investigational Site
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Mylan Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Mylan Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Mylan Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Mylan Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mylan Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Mylan Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Mylan Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Mylan Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Mylan Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Mylan Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Mylan Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Mylan Investigational Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Mylan Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Mylan Investigational Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Mylan Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Mylan Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Mylan Investigational Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Mylan Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Mylan Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E IM7
Country
Canada
Facility Name
Mylan Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Mylan Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Mylan Investigational Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Mylan Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Mylan Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Mylan Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Mylan Investigational Site
City
Broumov
ZIP/Postal Code
55016
Country
Czechia
Facility Name
Mylan Investigational Site
City
Bruntal
ZIP/Postal Code
792 01
Country
Czechia
Facility Name
Mylan Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 00
Country
Czechia
Facility Name
Mylan Investigational Site
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Mylan Investigational Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Mylan Investigational Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Mylan Investigational Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Mylan Investigational Site
City
Parnu
ZIP/Postal Code
80018
Country
Estonia
Facility Name
Mylan Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Mylan Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Mylan Investigational Site
City
Hohenmölsen
State/Province
Anhalt
ZIP/Postal Code
06679
Country
Germany
Facility Name
Mylan Investigational Site
City
Wangen im Allgau
State/Province
Baden Wuerttemberg
ZIP/Postal Code
88239
Country
Germany
Facility Name
Mylan Investigational Site
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
Mylan Investigational Site
City
Schweinfurt
State/Province
Bayern
ZIP/Postal Code
97421
Country
Germany
Facility Name
Mylan Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Mylan Investigational Site
City
Muenster
State/Province
Nordrhein Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Mylan Investigational Site
City
Sankt Ingbert
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
Mylan Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Mylan Investigational Site
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Mylan Investigational Site
City
Hamburg
ZIP/Postal Code
22603
Country
Germany
Facility Name
Mylan Investigational Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Mylan Investigational Site
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Mylan Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Mylan Investigational Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Mylan Investigational Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Mylan Investigational Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Mylan Investigational Site
City
Letavertes
ZIP/Postal Code
4281
Country
Hungary
Facility Name
Mylan Investigational Site
City
Mako
ZIP/Postal Code
H-6900
Country
Hungary
Facility Name
Mylan Investigational Site
City
Miskolc
ZIP/Postal Code
3530
Country
Hungary
Facility Name
Mylan Investigational Site
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Mylan Investigational Site
City
Kuldiga
ZIP/Postal Code
LC-3301
Country
Latvia
Facility Name
Mylan Investigational Site
City
Limbazi
ZIP/Postal Code
4001
Country
Latvia
Facility Name
Mylan Investigational Site
City
Ogre
ZIP/Postal Code
LV-5001
Country
Latvia
Facility Name
Mylan Investigational Site
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Mylan Investigational Site
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
Facility Name
Mylan Investigational Site
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Mylan Investigational Site
City
Sigulda
ZIP/Postal Code
LV-3200
Country
Latvia
Facility Name
Mylan Investigational Site
City
Talsi
ZIP/Postal Code
LV-3200
Country
Latvia
Facility Name
Mylan Investigational Site
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Mylan Investigational Site
City
Baia Mare
ZIP/Postal Code
430222
Country
Romania
Facility Name
Mylan Investigational Site
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Mylan Investigational Site
City
Bucuresti
ZIP/Postal Code
061072
Country
Romania
Facility Name
Mylan Investigational Site
City
Buzau
ZIP/Postal Code
120203
Country
Romania
Facility Name
Mylan Investigational Site
City
Cluj Napoca
ZIP/Postal Code
400349
Country
Romania
Facility Name
Mylan Investigational Site
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Mylan Investigational Site
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Mylan Investigational Site
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Mylan Investigational Site
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
Mylan Investigational Site
City
Timisoara
ZIP/Postal Code
300456
Country
Romania
Facility Name
Mylan Investigational Site
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Bratislava
ZIP/Postal Code
82106
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Bratislava
ZIP/Postal Code
83331
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Dolny Kubin
ZIP/Postal Code
02601
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Lubochna
ZIP/Postal Code
03491
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Nove Mesto nad Vahom
ZIP/Postal Code
91501
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Nove Zamky
ZIP/Postal Code
94002
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Presov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Prievidza
ZIP/Postal Code
97101
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Pruske
ZIP/Postal Code
01852
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Sabinov
ZIP/Postal Code
08301
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Skalica
ZIP/Postal Code
90901
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Sturovo
ZIP/Postal Code
943 01
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Trebisov
ZIP/Postal Code
07501
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Mylan Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Mylan Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Mylan Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Mylan Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Mylan Investigational Site
City
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Mylan Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Mylan Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Mylan Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Mylan Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
Facility Name
Mylan Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Mylan Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Mylan Investigational Site
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Mylan Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34174848
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.
Results Reference
derived

Learn more about this 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)

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