Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments mylan's insulin glargine, lantus®
Phase phase 3
Sponsor Mylan Inc.
Collaborator Mylan GmbH
Start date August 2014
End date June 2016
Trial size 500 participants
Trial identifier NCT02227862, MYL-GAI-3001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Receive both Mylan's insulin glargine plus insulin lispro.
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.
(Active Comparator)
receive Lantus® plus insulin lispro
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.

Primary Outcomes

Measure
Change in HbA1c from baseline to 24 weeks
time frame: 24 weeks

Secondary Outcomes

Measure
Immunogenicity: Change from baseline in titer and incidence of ADA
time frame: Baseline, 6, 12, 24 and 52 weeks
Rate per 30 days of hypoglycemic events
time frame: Baseline, 6, 12, 24 and 52 weeks
Insulin dose per body weight (U/kg)
time frame: Baseline, 6, 12, 24 and 52 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
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®.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Mylan Inc..