Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analog Glargine in Type 1 Diabetic Patients
Information source: Wockhardt
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type I Diabetes
Intervention: Wockhardt's Glargine (Glaritus) (Biological); Sanofi-Aventis' Glargine (Lantus) (Biological)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Wockhardt
Official(s) and/or principal investigator(s):
Rasendrakumar Jha, M.D., Study Director, Affiliation: Wockhardt
Swati Ranade, Phone: +91 22 26534444, Ext: 6241, Email: firstname.lastname@example.org
This is an open label, randomized, parallel group comparison of the immunogenicity safety of
Wockhardt's recombinant insulin analog Glargine (Glaritus«) and Sanofi-Aventis' recombinant
insulin analog Glargine (Lantus«) in Type 1 diabetics.
There are two phases of the study, which are as follows:
1. Phase 1 is a comparative phase in which there will be 2 arms (Lantus« arm and the
2. Phase 2 is a follow up phase only applicable to the Glaritus« Arm.
The study will last for 54 weeks for the patients enrolled in the Glaritus arm and
approximately 28 weeks for the patients enrolled in the comparator arm.
Two hundred and forty two patients will be enrolled considering an estimated dropout rate of
15% for a sample size of approximately 105 evaluable patients per arm. The total planned
enrollment period for this study is approximately 4 months (120 days).
Official title: An Open Label, Randomized Comparison of the Immunogenicity Safety of Wockhardt's Insulin Analogue Glargine (Glaritus) With Sanofi Aventis' Insulin Analogue Glargine (Lantus) in Type 1 Diabetic Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbAlc from baseline to 6 months of treatment between Glaritus and Lantus(as surrogate indicator of change in insulin antibodies titers between the two treatment arms).
Change in HbA1c, anti insulin antibodies (AIA) and insulin neutralizing antibodies (INA).
The percent change at 6 months from the baseline in the level of serum AIA & INA in the Glaritus arm with percent change in the level of serum AIA & INA in the Lantus arm.
The change in the glargine dose between Glaritus arm with Lantus arm after the 3rd and 6th month
The percent change at 12 months from the baseline in the level of serum AIA & INA in the Glaritus arm
Change in HbAlc from baseline to 12 months of treatment in Glaritus arm
In both the groups, the correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated.
To evaluate and compare the Immunogenicity Safety of Wockhardt's recombinant insulin
analogue Glargine (Glaritus┬«) with Sanofi-Aventis' recombinant insulin analogue Glargine
(Lantus┬«) in the United States on the basis of the effects of the anti insulin antibodies
generated following administration of these insulins on their efficacy and safety in Type I
The study is designed with the primary objective of change in HbAlc from baseline to 6
months of treatment between Glaritus and Lantus┬« USA (as surrogate indicator of change in
insulin antibodies titers between the two treatment arms). The secondary objective of the
study is to measure the correlation between change in HbA1c from baseline to 6 and 12 months
of treatment and change in anti insulin and neutralizing antibodies with insulin dose as
covariate. In both the groups, the correlation of the immunogenicity (measured as percentage
change in serum AIA & INA) with hypoglycemia, local allergic reactions and systemic allergic
reactions will be evaluated. Patient safety will be assessed through the monitoring and
reporting of any adverse events including laboratory change(s) that occur during the study.
Minimum age: 18 Years.
Maximum age: 45 Years.
1. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not
less than 1 year
2. Patients, who at the time of screening, have fasting C-peptide < 0. 5 nmol/L and have
been on an insulin regimen for at least 12 months prior to screening in the trial
3. Patients who have been on a stable basal regimen of recombinant human insulin for at
least 3 weeks prior to screening. A stable basal regimen is defined as the dose
staying within +/- 15%.
4. Male or Female Patients > 18 and < 45 years of age.
5. Patients with body mass index (BMI) of 18. 0 to 30. 0 kg/m2
6. Patients with glycosylated hemoglobin (HbA1c) levels between 7. 0 and 10%
7. Patients who are cooperative, reliable, and agree to have regular injections of
insulin and are willing to comply with protocol procedures.
8. Female patients (non-pregnant and non-lactating with adequate protection from
conception). Females of childbearing potential must agree to use an acceptable method
of birth control (including barrier-method contraceptives or intrauterine device
during the study). Women with history of bilateral tubal ligation, women who have
undergone total hysterectomy or women who are two years post-menopausal are also
eligible (if within > 18 and < 45 years age limits).
1. A Patient who is pregnant (as confirmed by a positive urine pregnancy test) or is
2. A Patient with history of no more than two episode of severe hypoglycemia within the
3. A Patient whose requirement for total daily dose of insulin is >1. 4 units/kg.
4. A Patient who has received Wockhardt's Glaritus┬«, Sanofi- aventis' Lantus┬« or any
other company's insulin glargine for the previous one year
5. A Patient with compromised hepatic or renal function, as shown by, but not limited
to, baseline AST or ALT >3 times the upper limit of normal range, serum creatinine
>2. 0 mg/dl and/or BUN >30 mg/dl, respectively. Abnormal findings should be discussed
with the medical monitor prior to the patient's entry.
6. A Patient who is an employee of the Investigator, or a patient who has a direct
involvement with the trial or other trials under the direction of the Investigator.
7. A Patient who has been treated with other investigational agent or devices within the
previous 30 days, has planned use of investigational drugs or devices, or has been
previously randomized in this trial.
8. A Patient with history or evidence of allergy to insulin preparations.
9. Patient who has received any insulin of animal origin during the last 3 years.
10. A Patients who is currently receiving or has received, within the last year, any
immunomodulators medications, including corticosteroids that would possibly modify
antibody generation either at the enrollment or during the course of the study.
Topical/ ophthalmic/intra-articular/nasal spray corticosteroids will be allowed.
11. Patients who are Hepatitis B or C positive on testing or have positive medical
history of HIV at screening.
12. Patients who received an oral hypoglycaemic agent within 4 weeks prior to signing
13. Has used GLP-1 analog (for example, exenatide) and nasal insulin within 3 months
prior to screening
14. Patients who have undergone pancreatectomy or pancreas/islet cell transplant
15. Patient with history or evidence of active severe proliferative retinopathy,
nephropathy and/or neuropathy, significant cardiovascular disease (including, but not
limited to, myocardial infarction, stroke, peripheral vascular disease, ischemic
changes at resting ECG), anemia or hemoglobinopathy, alcohol or drug abuse or any
other medical condition that in the opinion of Investigator can interfere with the
16. Patients unlikely to comply with the study protocol e. g. unable to return
periodically for subsequent visits.
17. Any form of alternative medication including homeopathic, ayurvedic, and herbal are
not allowed, 8 weeks prior to the screening and throughout the study duration.
18. A Patient who is diagnosed as hyperthyroid or hypothyroid state at the time of
screening will be excluded from the study. However, earlier diagnosed patients (with
a history of hyperthyroidism or hypothyroidism) who are well controlled on treatment
(Euthyroid) can be considered for enrollment in the study, provided patient is on a
stable dose for 1 month prior to screening and is continued on the same dose
throughout the study.
19. Patients with a history of unhealed diabetic ulcer
Locations and Contacts
Swati Ranade, Phone: +91 22 26534444, Ext: 6241, Email: email@example.comAdditional Information
Starting date: July 2011
Last updated: May 10, 2011