Clinical Trials List
Protocol NumberMYL-GAI-3002
NCT Number(ClinicalTrials.gov Identfier)NCT02227875
2014-07-31 - 2014-09-30
Phase III
Terminated7
ICD-10E11.9
Type 2 diabetes mellitus without complications
An open-label, randomized, multi-center, parallel grouped clinical trial comparing the efficacy and safety of Mylan's Insulin Glargine and Lantus® for patients with type 2 diabetes.
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Mylan GmbH
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 李宇力 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 王子源 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Type 2 diabetes
Objectives
Main goal: According to the change of glycosylated hemoglobin (HbA1c) from the baseline to 24 weeks, to verify whether the once-daily Mylan insulin glargine is not inferior to the once-daily Randez (both are combined with other anti-diabetic drug). Secondary objective: To compare Mylan insulin glargine with RANDS at 24 weeks (unless otherwise noted) under the condition that both are used in combination with other oral antidiabetic drugs according to the following indicators: hypoglycemia events every 30 days Incidence rate, and the number of hypoglycemic events; The number of local reactions, systemic reactions and other adverse events that occurred over time; The change in immunogenicity over time from the baseline (titer, anti-drug antibody [ADA] , Changes in the incidence of anti-HCP antibodies and neutralizing antibodies) comparison; equipment-related safety assessment; changes in glycated hemoglobin from the reference point to 12 weeks; changes in fasting blood glucose values from the reference point over time; The change of basal insulin dose per unit body weight (U/kg) from the reference point over time; the change of self-monitoring blood glucose (SMBG) data at 7 time points from the reference point over time; the glycated hemoglobin <7% at the end of the test Patient ratio
Test Drug
Mylan′s Insulin Glargine
Active Ingredient
Insulin Glargine
Dosage Form
Injection
Dosage
100
Endpoints
Main evaluation indicators (average change of glycosylated hemoglobin from the reference point to the 24th week)
Inclution Criteria
1. The patient must complete the instructions and sign the consent form before beginning any procedures specific to the trial program; in the United States, the patient must also sign the IHS-810 form "Authorization for the Use or Disclosure of Protected Health Information" , In order to complete the authorization (according to the United States Health Insurance Portability and Accountability Act of 1996 [HIPAA]).
2. Patients aged ≥18 years and ≤65 years old, regardless of gender.
3. Patients who have been diagnosed as type 2 diabetes according to the standards of the American Diabetes Association 2014 and meet the following conditions:
• The diagnosis was established 1 year before screening
• C peptide test (if the test host suspects latent autoimmune diabetes, this test can be performed)
• Before screening, received other anti-diabetic drugs at a stable dose for 3 months
• Have not been treated with insulin or
• Before screening, have received RANDEX once daily treatment for at least 3 months at a stable dose (the dose can have a variability of ±15%).
4. At the time of screening, the body mass index (BMI) is ≥18.50 and ≤40.00 kg/m2.
5. The body weight remained stable within 3 months before screening (the increase or decrease did not exceed 5 kg); this information will be collected in the patient interview by asking for medical history.
6. When screening, hemoglobin ≥9.0 g/dL.
7. At the time of screening, patients with glycosylated hemoglobin (HbA1c) <10.5% or who have not received insulin treatment are between 7.5-10.5%.
8. The patient's ability to communicate appropriately with the trial host.
9. The patient’s ability and willingness to comply with the regulations in the trial plan, including self-monitoring of blood glucose (SMBG) at 7 time points, daily completion of patient log records, and compliance with the recommendations of this trial throughout the trial period. Good diet and exercise plan.
10. Female patients must meet the following conditions:
• Female patients with fertility must continue to use two acceptable contraceptive methods (for example, intrauterine contraceptive device and condom, spermicidal gel and insurance) from the beginning of the screening period, throughout the trial period, and until the end of the trial. Condoms, contraceptive diaphragms and condoms, etc.).
• Periodic abstinence (such as safety period, ovulation period, symptomatic body temperature, post-ovulation contraception) and external ejaculation are not acceptable methods of contraception.
• Women after menopause must have had no menstrual cramps for at least 1 year before screening.
• Female patients who report that they have been surgically sterilized must complete the operation at least 6 months before screening.
• All female patients must obtain a negative pregnancy test result during screening and each outpatient visit.
• If the male partner of a female patient has had a vasectomy, the operation must have been performed more than 6 months before screening.
2. Patients aged ≥18 years and ≤65 years old, regardless of gender.
3. Patients who have been diagnosed as type 2 diabetes according to the standards of the American Diabetes Association 2014 and meet the following conditions:
• The diagnosis was established 1 year before screening
• C peptide test (if the test host suspects latent autoimmune diabetes, this test can be performed)
• Before screening, received other anti-diabetic drugs at a stable dose for 3 months
• Have not been treated with insulin or
• Before screening, have received RANDEX once daily treatment for at least 3 months at a stable dose (the dose can have a variability of ±15%).
4. At the time of screening, the body mass index (BMI) is ≥18.50 and ≤40.00 kg/m2.
5. The body weight remained stable within 3 months before screening (the increase or decrease did not exceed 5 kg); this information will be collected in the patient interview by asking for medical history.
6. When screening, hemoglobin ≥9.0 g/dL.
7. At the time of screening, patients with glycosylated hemoglobin (HbA1c) <10.5% or who have not received insulin treatment are between 7.5-10.5%.
8. The patient's ability to communicate appropriately with the trial host.
9. The patient’s ability and willingness to comply with the regulations in the trial plan, including self-monitoring of blood glucose (SMBG) at 7 time points, daily completion of patient log records, and compliance with the recommendations of this trial throughout the trial period. Good diet and exercise plan.
10. Female patients must meet the following conditions:
• Female patients with fertility must continue to use two acceptable contraceptive methods (for example, intrauterine contraceptive device and condom, spermicidal gel and insurance) from the beginning of the screening period, throughout the trial period, and until the end of the trial. Condoms, contraceptive diaphragms and condoms, etc.).
• Periodic abstinence (such as safety period, ovulation period, symptomatic body temperature, post-ovulation contraception) and external ejaculation are not acceptable methods of contraception.
• Women after menopause must have had no menstrual cramps for at least 1 year before screening.
• Female patients who report that they have been surgically sterilized must complete the operation at least 6 months before screening.
• All female patients must obtain a negative pregnancy test result during screening and each outpatient visit.
• If the male partner of a female patient has had a vasectomy, the operation must have been performed more than 6 months before screening.
Exclusion Criteria
1. Past or present suffering from a medical condition or disease that makes the trial leader believe that participating in the trial will bring unacceptable risks to the patient.
2. For the insulin/insulin analog preparations used in this test, have ever been allergic to any of the active or inactive ingredients, or have had a significant drug allergic reaction.
3. Have used animal insulin in the past 3 years, used any insulin other than RANDEX in the 3 months before screening, or used biosimilar drugs with insulin glargine at any point before screening.
4. You need to receive basic bolus insulin therapy, or the test host determines that you need to administer insulin during meals to achieve blood sugar control.
5. Regularly received immunomodulatory treatment within 1 year before screening.
6. Has ever suffered from a clinically significant autoimmune disease determined by the trial host (recorded at the time of medical history), but does not include fully treated autoimmune thyroid disease (see also exclusion criteria item 16).
7. There have been ≥2 severe hypoglycemia events in the 6 months before screening, or hypoglycemia unawareness has occurred as judged by the test host (please see the sample questionnaire in Appendix I).
8. There have been ≥1 hyperglycemia and hyperosmotic coma events in the 6 months prior to screening, or emergency medical treatment and final hospitalization due to uncontrolled diabetes.
9. Acute bacterial, viral, or fungal systemic infections (recorded at the time of medical history) that were clinically significant (that is, according to the trial host's judgment, are significant enough to change the insulin dose requirement) occurred within 4 weeks before screening.
10. In the electrocardiogram (ECG) or safety laboratory test (liver function test, kidney function test, hematology test or any other laboratory test results judged by the test host as clinically relevant) during the screening, any A major clinical abnormality.
11. There is serological evidence that patients have human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen [HbSAg]) or hepatitis C (HCVAb) antibodies in their body at the time of screening.
12. Relied on or abused drugs or alcohol within 1 year before screening.
13. Other study drugs have been used within 3 months before screening (or the length of time set by local regulations), or the time point of screening return falls within 5 half-lives after the last use of other study drugs (whichever is longer) , Or book to use other study drugs during the trial period.
14. Patients with the following secondary complications of diabetes:
• Mydriatic ophthalmoscope/retinal photography performed within 6 months before screening confirmed that he has active proliferative retinopathy.
2. For the insulin/insulin analog preparations used in this test, have ever been allergic to any of the active or inactive ingredients, or have had a significant drug allergic reaction.
3. Have used animal insulin in the past 3 years, used any insulin other than RANDEX in the 3 months before screening, or used biosimilar drugs with insulin glargine at any point before screening.
4. You need to receive basic bolus insulin therapy, or the test host determines that you need to administer insulin during meals to achieve blood sugar control.
5. Regularly received immunomodulatory treatment within 1 year before screening.
6. Has ever suffered from a clinically significant autoimmune disease determined by the trial host (recorded at the time of medical history), but does not include fully treated autoimmune thyroid disease (see also exclusion criteria item 16).
7. There have been ≥2 severe hypoglycemia events in the 6 months before screening, or hypoglycemia unawareness has occurred as judged by the test host (please see the sample questionnaire in Appendix I).
8. There have been ≥1 hyperglycemia and hyperosmotic coma events in the 6 months prior to screening, or emergency medical treatment and final hospitalization due to uncontrolled diabetes.
9. Acute bacterial, viral, or fungal systemic infections (recorded at the time of medical history) that were clinically significant (that is, according to the trial host's judgment, are significant enough to change the insulin dose requirement) occurred within 4 weeks before screening.
10. In the electrocardiogram (ECG) or safety laboratory test (liver function test, kidney function test, hematology test or any other laboratory test results judged by the test host as clinically relevant) during the screening, any A major clinical abnormality.
11. There is serological evidence that patients have human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen [HbSAg]) or hepatitis C (HCVAb) antibodies in their body at the time of screening.
12. Relied on or abused drugs or alcohol within 1 year before screening.
13. Other study drugs have been used within 3 months before screening (or the length of time set by local regulations), or the time point of screening return falls within 5 half-lives after the last use of other study drugs (whichever is longer) , Or book to use other study drugs during the trial period.
14. Patients with the following secondary complications of diabetes:
• Mydriatic ophthalmoscope/retinal photography performed within 6 months before screening confirmed that he has active proliferative retinopathy.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
560 participants
