Type 1 Diabetes Mellitus MedDRA version: 17.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
MYLAN GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written and signed informed consent needs to be provided by patients or their legal representatives before starting any protocol-specific procedures. 2. Male and female patients between the ages of 18 to 65 years, both ages inclusive. 3. Patients with an established diagnosis of T1DM per ADA 2014 criteria who also fulfil the following criteria: o Initiation of insulin treatment within 6 months of T1DM diagnosis o Treatment with basal-bolus insulin therapy for at least 1 year before screening o Fasting plasma C-peptide =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. medical condition or disease that in the investigator’s opinion would place the patient at an unacceptable risk from study participation. 2. 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. 3. use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior. 4. use of a regular immunomodulator therapy in the 1 year prior to screening. 5. autoimmune disorders other than T1DM or insufficiently treated autoimmune thyroid disorders (see also exclusion criteria 15), judged clinically relevant by the investigator 6. =2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness, as judged by the investigator. 7. =1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening. 8. clinically significant acute bacterial, viral or fungal systemic infections in the last 4 weeks prior to screening 9. Any clinically significant abnormality in ECG or safety laboratory tests conducted at screening. 10. Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening. 11. History of drug or alcohol dependence or abuse during the 1 year prior to screening. 12. 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 received (whichever is longer), or scheduled to receive another investigational drug during the current trial period. 13. Following secondary complications of diabetes: • Active proliferative retinopathy as confirmed by a dilated ophthalmoscopy/retinal photography examination performed within the 6 months prior to screening. • Clinical nephrotic syndrome or diabetic nephropathy with a serum creatinine level >1.5 times of upper limit of reference range at screening • Severe form of neuropathy (mild and moderate will be included) or cardiac autonomic neuropathy (mild and moderate will be included) • history of limb amputation as a complication of diabetes (at any time), or any vascular procedure during the 1 year prior to screening. • diabetic foot or diabetic ulcers in the 1 year prior to screening. 14. Any elective surgery requiring hospitalization planned during the trial period. 15. Clinically significant major organ disorder at the time of screening including: • Uncontrolled hypertension • Uncontrolled hyperlipidemia • Uncontrolled hyperthyroidism or hypothyroidism • Impaired hepatic function. Patients with evidence of Gilberts disease may be included in the trial if they have total bilirubin of 80% of the total bilirubin. 16. History of a significant medical condition, such as: • Clinically significant cardiac disease like unstable angina, myocardial infarction, grade 3 or 4 congestive heart failure (CHF) according to New York Heart Association criteria, valvular heart disease, cardiac arrhythmia requiring treatment, and pulmonary hypertension; during the year prior to screening. • Stroke or transient ischemic attack (TIA) in the 6 months before screening. 17. Patients with major depressive illness in the last 3 years (those who have well controlled depression for 3 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To compare Mylan’s insulin glargine to Lantus®, at 24 weeks and 52 weeks, when administered in combination with mealtime insulin lispro with respect to: 1. Immunogenicity: change from baseline in titer, incidence of ADA, anti-HCP and neutralizing antibodies 2. Rate per 30 days of hypoglycemic events. 3. Occurrence of local reactions, systemic reactions and other adverse events 4. Device-related safety assessment 5. Change in HbA1c from baseline at other scheduled visits 6. Change in fasting plasma glucose from baseline 7. Change in basal insulin dose per unit body weight (U/kg) from baseline 8. Change in 8-point SMBG profile from baseline 9. Proportion of participants with HbA1c <7% at 24 weeks ;Primary end point(s): Change in HbA1c from baseline to 24 weeks;Timepoint(s) of evaluation of this end point: at study week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. At screening, and at study weeks 0, 2, 4, 12, 24, 36 and 52 2. every 30 days 3. at each study visit 4. at each study visit 5. at screening and at study weeks 0, 12, 36 and 52 6. at screening and at study weeks -6, -4, -2, 0, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52 7. at each study visit 8. at each study visit 9. at study week 24;Secondary end point(s): 1. Immunogenicity: change from baseline in titer, incidence of ADA, anti-HCP and neutralizing antibodies 2. Rate per 30 days of hypoglycemic events. 3. Occurrence of local reactions, systemic reactions and other adverse events 4. Device-related safety assessment 5. Change in HbA1c from baseline at other scheduled visits 6. Change in fasting plasma glucose from baseline 7. Change in basal insulin dose per unit body weight (U/kg) from baseline 8. Change in 8-point SMBG profile from baseline 9. Proportion of participants with HbA1c <7% at 24 weeks | — |
Countries
Canada, Czech Republic, Estonia, Germany, Hungary, Latvia, Romania, Slovakia, South Africa, United Kingdom, United States
Contacts
Public ContactJulia Moore,Clinical Project Manage
Mylan, Inc
Outcome results
None listed