Open label, phase 3 trial comparing Mylans Glargine with Lantus
Research type
Research Study
Full title
MYL-GAI-3001. AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PARALLEL-GROUP CLINICAL TRIAL COMPARING THE EFFICACY AND SAFETY OF MYLANS INSULIN GLARGINE WITH LANTUS® IN TYPE 1 DIABETES MELLITUS PATIENTS.
IRAS ID
157047
Contact name
Sudesna Chatterjee
Contact email
Sponsor organisation
Mylan Pharmaceuticals Inc
Eudract number
2014-000747-32
Clinicaltrials.gov Identifier
105279, US IND Number
Research summary
Insulin secretion in healthy subjects is characterised by relatively constant basal insulin secretion with a post-prandial (after eating a meal) surge. Type 1 diabetes mellitus (T1DM) is characterised by loss of the insulin-producing beta-cells of the islets of Langerhans in the pancreas, leading to a deficiency of insulin. The principal treatment of patients with T1DM is initiation of insulin and diet control and careful monitoring of blood glucose levels
This trial is a multicenter, open-label, randomised, parallel-group phase 3 trial in patients with type 1 diabetes (T1DM) comparing the efficacy, immunogenicity and safety of Mylan’s insulin glargine with that of Lantus®.
After a 4-week screening period, all patients will be titrated on Lantus® during a 6-week run-in period, and will be shifted from their current mealtime insulin to Humalog®. The patients will be randomised; one group will continue on Lantus®, while the other group will receive Mylan’s insulin glargine for 52 weeks. After 52 weeks all patients will be put back on Lantus®. A follow-up visit will be scheduled 4 weeks afterwards.
After all patients have been exposed to 24 weeks of treatment, an interim database lock followed by an interim analysis will be performed.
Approximately 500 patients with type 1 diabetes will participate in this trial. Patients will be randomised to one of the two groups (Mylan’s insulin glargine plus insulin lispro, or Lantus® plus Humalog®) in a 1:1 ratio.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1068
Date of REC Opinion
13 Aug 2014
REC opinion
Favourable Opinion