AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PARALLEL-GROUP CLINICAL TRIAL COMPARING THE EFFICACY AND SAFETY OF MYLAN’S INSULIN GLARGINE WITH LANTUS® IN TYPE 1 DIABETES MELLITUS PATIENTS

MYLAN GmbH0 个研究点目标入组 500 人开始时间: 2014年8月11日最近更新: 2017年2月13日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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 <0.3 nmol/L at screening
•o Patient has been on once daily Lantus® at stable dose (±15% variation in dose) for at least 3 months at screening
•4. Body mass index (BMI) of 18.5 to 35 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, this information will be collected by patient interview during medical history.
•6. Glycosylated hemoglobin (HbA1c) =9.5% at screening.
•7. Hemoglobin =9.0 g/dL at screening.
•8. Patient has the capability of communicating appropriately with the investigator.
•9. Patient is able and willing to comply with the requirements of the trial protocol including the 8-point self-monitored blood glucose (SMBG), completion of patient diary records and following a recommended diet and exercise plan for the entire duration of the trial.
•10. Female patients of childbearing potential who are willing to use 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 regular 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 clinic visits, 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 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 490
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10
•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 <0.3 nmol/L at screening
•o Patient has been on once daily Lantus® at stable dose (±15% variation in dose) for at least 3 months at screening
•4. Body mass index (BMI) of 18.5 to 35 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, this information will be collected by patient interview during medical history.
•6. Glycosylated hemoglobin (HbA1c) =9.5% at screening.
•7. Hemoglobin =9.0 g/dL at screening.
•8. Patient has the capability of communicating appropriately with the investigator.
•9. Patient is able and willing to comply with the requirements of the trial protocol including the 8-point self-monitored blood glucose (SMBG), completion of patient diary records and following a recommended diet and exercise plan for the entire duration of the trial.
•10. Female patients of childbearing potential who are willing to use 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 regular 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 clinic visits, 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 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 490
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10
另有 25 项未显示

排除标准

•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 and making the patient ineligible for the study (as per investigator).
•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 (by a person legally authorized to do so).
•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 or cardiac autonomic neuropathy. Patients with mild or moderate forms of neuropathy will be allowed.
•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 <3 mg/dL with indirect bilirubin contributing to >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.
•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 and making the patient ineligible for the study (as per investigator).
•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 (by a person legally authorized to do so).
•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 or cardiac autonomic neuropathy. Patients with mild or moderate forms of neuropathy will be allowed.
•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
另有 31 项未显示

研究者

发起方

MYLAN GmbH

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