Skip to main content
OpenTrials
Completed

NCT Number: 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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mylan Investigational Site, Red Deer, Alberta, Canada

Loading trial locations.

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mylan's insulin glargine

Drug

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®

Drug

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 outcomes

  1. Change in HbA1c From Baseline to 24 Weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Summary of Actual and Change From Baseline in HbA1c

    Time frame: 24 and 52 weeks

  2. Change From Baseline in FPG Over Time

    Time frame: 24 and 52 weeks

  3. Change From Baseline in 8-point SMBG Profile Over Time

    Time frame: 24 and 52 weeks

  4. Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time

    Time frame: 24 and 52 weeks

  5. Rate of Hypoglycemic Events Per 30 Days Over Time

    Time frame: 24 and 52 weeks

  6. Hypoglycemia Occurrence

    Time frame: 52 weeks

  7. Occurrence of Local and Systematic Reactions

    Time frame: 52 weeks

  8. Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time

    Time frame: 24 and 52 weeks

  9. Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time

    Time frame: 24 and 52 weeks

  10. Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time

    Time frame: 24 and 52 weeks

  11. Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time

    Time frame: 24 and 52 weeks

  12. Proportion of Patients With HbA1c < 7%

    Time frame: 24 and 52 weeks

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Mylan GmbH

Registry information

Official study 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

Acronym: INSTRIDE 1

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2014
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.