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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) | Clinical Trials | Clareo Health

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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)

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

NCT02227862•Mylan Inc.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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.

Locations (162)

Mylan Investigational Site

Bell Gardens, California, United States

Mylan Investigational Site

Fresno, California, United States

Mylan Investigational Site

Greenbrae, California, United States

Mylan Investigational Site

La Jolla, California, United States

Mylan Investigational Site

La Mesa, California, United States

Mylan Investigational Site

Long Beach, California, United States

Mylan Investigational Site

Los Gatos, California, United States

Mylan Investigational Site

Mission Hills, California, United States

Mylan Investigational Site

National City, California, United States

Mylan Investigational Site

Northridge, California, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

March 3, 2022

Enrollment

558

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Mylan's insulin glargine

DRUG

Lantus®

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Dysautonomia in Children With Type 1 Diabetes

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Lipoprotein Kinetics in T1D

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery