A phase 3 clinical trial to compare the efficacy and safety of Mylan's InsulinGlargine with commercial Insulin Glargine (Lantus®) in patients with type2 diabetes
- Conditions
- Type 2 Diabetes mellitusMedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-000881-23-SK
- Lead Sponsor
- MYLAN GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 560
1. Patients must give written and signed informed consent before starting any protocol-specific procedures;
2. Male and female patients between the ages of 18 to 65 years, both ages inclusive.
3. a. Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:
- Diagnosis established 1 year prior to screening
- C-peptide testing (can be done if investigator suspects latent autoimmune diabetes)
- On stable dose of other anti-diabetic drugs for 3 months prior to screening
b. Patients must also be insulin-naïve (insulin-naïve” means the patient was never prescribed an insulin/insulin analogue on a regular basis. Occasional use for up to 2 weeks while admitted in a hospital will not be considered as insulin use, and the patient will still be considered naïve)
OR
- If not insulin-naïve, on Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening
4. Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).
5. Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening;
6. Hemoglobin =9.0 g/dL at screening.
7. Glycosylated hemoglobin (HbA1c) of <10.5% at screening or >7.5 to 8. The patient has the capability of communicating appropriately with the investigator.
9. The patient is able and willing to comply with the requirements of the trial protocol including the 7-point self-monitored blood glucose (SMBG), completion of daily patient diary records and following a recommended diet and exercise plan for the entire duration of the trial.
10. Female patients complying with the following:
- Female patients of childbearing potential must be using oral contraception or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion.
- 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 screening.
- Female patients who report surgical sterilization must have had the procedure at least 6 months prior to screening.
- All female patients of childbearing potential must have negative pregnancy test results at screening and at each clinic visit.
- If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to screening.
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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. History or presence of a medical condition/disease that in the investigator's opinion would place the patient at an unacceptable risk.
2. hypersensitivity to any of the active/inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions.
3. 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.
4. Patients requiring basal-bolus insulin therapy or mealtime insulin in order to achieve glycemic control.
5. Regular use of immune-modulator therapy in the 1 year prior to screening.
6. autoimmune disorders other than sufficiently treated autoimmune thyroid disorders, judged clinically relevant by the investigator
7. =2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness as judged by theinvestigator.
8. =1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
9. 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 screening
10. Any clinically significant abnormality in electrocardiogram or safety laboratory tests (liver function test, renal function test, hematology or any other laboratory result) conducted at screening and making the patient ineligible for the study (as per investigator).
11. Serological evidence of human immunodeficiency virus, hepatitis B or hepatitis C antibodies at screening.
12. drug/alcohol dependence or abuse during the 1 year prior to screening.
13. Receipt of another investigational drug (IMP) in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another IMP (whichever is longer), or scheduled to receive another IMP during the current trial period.
14. Following secondary complications of diabetes:
- Active proliferative retinopathy as confirmed by a dilated ophthalmoscopy/retinal photography examination performed within 6 months prior to screening (performed by a person legally authorized to do so).
- Clinical nephrotic syndrome or diabetic nephropathy having serum creatinine level >1.5 times of upper limit of reference range at screening.
- History of severe form of neuropathy or cardiac autonomic neuropathy (Patients with mild/moderate forms of neuropathy will be allowed)
- Patients with limb amputation as a complication of diabetes (at any time) or any vascular procedure during the 1 year prior to screening.
- diabetic foot or non-healing diabetic ulcers in the 1 year prior to screening.
15. Any major elective surgery requiring hospitalization planned during the trial period.
16. Clinically significant major organ disease at the time of screening including:
Uncontrolled hypertension; defined as stage 2 hypertension by Joint National Committee VII; Uncontrolled hyperlipidemia, hyperthyroidism or hypothyroidism; Impaired hepatic function. Patients with evidence of Gilberts disease may be included in the trial if they have total bilirubin of <3 mg/dL with indirect bilirubin contributing to >80% of the total
bilirubin.
17. Significant medical condition such as:
- Clinically significant cardiac disease like unstable angina, myoc
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method