This trial is active, not recruiting.

Condition type 2 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 600 participants
Trial identifier NCT02227875, MYL-GAI-3002


To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks

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
receive Mylan's insulin Glargine
mylan's insulin glargine
Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
(Active Comparator)
receive Lantus®
For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Primary Outcomes

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

Secondary Outcomes

Rate of hypoglycemic events per 30 days and hypoglycemia occurrence
time frame: Baseline and up to 24 weeks
Immunogenicity: Change in antibody titer
time frame: Baseline and up to 24 weeks

Eligibility Criteria

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

Inclusion Criteria: - Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following: - Diagnosis established 1 year prior to screening - Insulin-naïve OR - On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening - Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive). - Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history. - Hemoglobin ≥9.0 g/dL at screening - Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening. Exclusion Criteria: - History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions. - History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening. - Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control. - Regular use of immune-modulator 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 episode of hyperglycemic hyperosmolar coma 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. - Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.

Additional Information

Description This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Mylan Inc..