Extension study of a phase 3 clinical trial to compare the efficacy and safety of Mylan's Insulin Glargine with commercial Insulin Glargine (Lantus®) in patients with type 1 diabetes
- Conditions
- Type 1 Diabetes MellitusMedDRA version: 18.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-004353-40-LV
- Lead Sponsor
- Mylan GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
1. Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study.
2. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
3. The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point SMBG, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the
extension study.
4. Female patients complying with the following:
- Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of
randomization throughout the entire study.
- Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study.
- Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-GAI-3001 study.
- All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES.
- If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to inclusion in MYL-GAI-3001 study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1. History or presence of a medical condition or disease that in the Investigator’s opinion would place the patient at an unacceptable risk from trial participation.
2. History of clinically significant (i.e., significant enough to alter the insulin dose requirement, as per the Investigator) acute bacterial, viral or fungal systemic infections in the 4 weeks prior to inclusion / randomization (recorded while collecting patient
history) in to the MYL-1501D-3003 extension study
3. Patients scheduled to receive another investigational drug during the extension study period
4. Any major elective surgery requiring hospitalization planned during the extension study period.
5. Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of =1.5 U/kg/day (Lantus® in U/kg/day or Mylan’s insulin glargine in IU/kg/day).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare changes in HbA1C in patients when Mylan’s insulin glargine and Lantus® are interchanged (Mylan’s insulin glargine and Lantus® are administered in combination with mealtime insulin lispro).;Secondary Objective: To compare:<br>- Change in basal insulin dose per unit body weight (U/Kg/day)<br>- Change in immunogenicity<br>- Rate of hypoglycemic events per 30 days; and occurrence of hypoglycemia<br>- Occurrence of local reactions, systemic reactions and other adverse events<br>- Change in fasting plasma glucose<br>- Change in 8-point SMBG profile<br>- Device-related safety assessments<br><br> in patients when Mylan’s insulin glargine and Lantus® are interchanged (Mylan’s insulin glargine and Lantus® are administered in combination with mealtime insulin lispro).<br>;Primary end point(s): HbA1c difference of change from baseline between two periods at<br>12 weeks.;Timepoint(s) of evaluation of this end point: At week 12 and week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy measures both actual and change in values:<br>1) Change in fasting plasma glucose from randomization;<br>2) SMBG value: individual pre-meal, individual post-meal, individual 2-hour excursion after meal, bedtime, overall (average) pre-meal, overall post-meal, overall excursion,<br>4-point average (pre-meal + bedtime), and daily average;<br>3) Daily prandial insulin, basal insulin, and total insulin dose/unit body weight for days of 8-point profiles.<br><br>Safety measures:<br>1) Immunogenicity analyzes<br>2) Hypoglycemia analyzes<br>3) Adverse events analyzes<br>4) Device safety assesment<br>;Timepoint(s) of evaluation of this end point: 1) Week 8, 12, 20, 24<br>2) Week 2, 4, 8, 12, 14, 16, 20, 24<br>3) Week 2, 4, 8, 12, 14, 16, 20, 24<br><br>Safety measures:<br>-at each study visit, until week 28 except immunogenicity until week 24<br>