CTRI/2011/11/002173 [Registered on: 28/11/2011] Trial Registered Prospectively
Last Modified On:
27/02/2012
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A comparative safety and efficacy of insulin analogue glargine in Type-1 diabetes patients.
Scientific Title of Study
An Open Label, Randomized, Comparative Trial of the Safety and Efficacy of Wockhardt’s Insulin analogue Glargine (Glaritus®) with Sanofi Aventis Insulin analogue Glargine (Lantus®) given along with meal time bolus of rapid acting insulin (Lispro) in Type 1 diabetic patients.
Secondary IDs if Any
Secondary ID
Registry
GLA/WOC/CT/010/11-12
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Department of Endocrinology, DXA Room, Ward 32 A, 9th Floor,New Building, Seth G. S. Medical College and K.E.M.Hospital,Acharya Donde Marg, Parel Mumbai
02224162917
nalinishah@gmail.com
Dr YSadasiva Rao
Yalamanchi Hospital and Resaerch Center
Door No.29-7-44,Venkataratnam Street,Suryaraopet,Vijayawada Krishna
Ethics Committee for Research on Human Subjects (ECRHS), Seth G.S. Medical College and K.E.M. Hospital,Mumbai. Site: Seth G. S. Medical College and K.E.M.Hospital
Submittted/Under Review
Ethics Committee for Research on Human Subjects,5-12-15 Krishna Nagar, Visakhapatnam-530002,India. Site: Endocrine and Diabetes Center, Vizag.
Submittted/Under Review
Ethics Committee of Biniwale Clinic, 852/1,Dinkar Baug Apartment,Bhandarkar Institute Road, Pune-411004,India. Site: Orange Diabetes Specialty Clinic, Clinical Research Unit
Science For Health,C/O Jnana Sanjeevni Medical Centre 2, 1A Cross, Marenahalli J.P Nagar 2nd Phase, Banglore-560078,India. Site: Jnana Sanjeevini Medical Center
Submittted/Under Review
Yalamanchi Hospital Ethics Committee, Yalamanchi Hospital and Research Centers Pvt Ltd, D.No:29-7-44Venkataratnam Street, Suryaraopet, Vijaywada-520002. Site: Yalamanchi Hospital and Resaerch Center Pvt Ltd.
Insulin analogue glargine manufactured by Wockhardt Ltd..
Starting Dose: 0.5 to 0.7 U/kg body weight;
Dose can be titrated based on the fasting blood glucose levels;
Frequency: Once daily at bedtime;
Duration: 12 weeks of study period;
Mode of administration: Subcuteneous;
Comparator Agent
Lantus
Insulin analogue glargine manufactured by Sanofi - Aventis.
Starting Dose: 0.5 to 0.7 U/kg body weight;
Dose can be titrated based on the fasting blood glucose levels;
Frequency: Once daily at bedtime;
Duration: 12 weeks of study period;
Mode of administration: Subcuteneous;
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
1. Subjects, 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 inclusion in the trial.
2. Subjects with glycosylated hemoglobin (HbA1c) levels between 8 and 10%.
3. Subjects with body mass index (BMI) 18.0 to 38.0 kg/m2.
4. Subjects who understand nature of trial & provide written informed consent.
5. Subjects who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
6. Female subjects who are not pregnant and not lactating. Females subjects of childbearing potential must agree to use an acceptable method of birth control (including barrier–method contraceptives or intrauterine device). Women with history of bilateral tubal ligation, women who have undergone total hysterectomy or women who are post-menopausal for atleast 2 years are eligible (if within ≥ 18 and ≤ 55 years age).
7. Ability to use the self glucose-monitoring device and to self administer insulin.
ExclusionCriteria
Details
1. A subject with impaired hepatic function, where liver enzymes (AST or ALT) levels are abnormal and are clinically significant as assessed by the Investigator, however not 3 times the upper limit of normal range.
2. A subject with impaired renal function, where serum creatinine 2.0 mg/dl and/or BUN 30 mg/dl.
3. A subject with serum AIA result 0.95 index value (i.e., “Borderline” or “Positive”).
4. A subject who is Hepatitis B or C or HIV positive.
5. A subject who is in a hyperthyroid or hypothyroid state will be excluded from the study. However, earlier diagnosed subjects (with a history of hyperthyroidism or hypothyroidism) who are well controlled on treatment (Euthyroid) can be considered for enrollment in the study.
6. A Subject whose requirement for total daily dose of insulin is 1.4 units/kg.
7. A subject with history or evidence of allergy to insulin preparations.
8. A subject with history or evidence of recurrent severe hypoglycemia.
9. A subject who has received any insulin of animal origin during the last 3 years.
10. A subject who is currently receiving or has received, within the last year, any immunomodulator 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. A subject who has received an oral hypoglycaemic agent within 4 weeks prior to screening.
12. A subject with history or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment.
13. A subject who has undergone pancreatectomy or pancreas/islet cell transplant.
14. A subject who has been treated with other investigational agent or devices within the previous 30 days.
15. A subject who is unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
16. A subject who is an employee of the Investigator, or a subject who has a direct involvement with the trial or other trials under the direction of the Investigator.
17. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in HbA1c
Baseline
End of trial
Secondary Outcome
Outcome
TimePoints
Change in dose between 2 arms.
Between randomization to end of trial.
Safety
Through out the trial
Target Sample Size
Total Sample Size="322" Sample Size from India="322"
Prospective, randomized, multicenter, comparative, non- inferiority, open-label, parallel group study. The total duration of the trial for each subject would be 17 weeks and number of subject visits are 6. The study visits are as follows:
1. Visit 1 / Screening
2. Visit 2 / Beginning of run-in period (for a period of 4 weeks)
3. Visit 3 / End of run in period / Randomization
4. Visit 4 / End of week 4 (from randomization)
5. Visit 5 / End of week 8 (from randomization)
6. Visit 6/ End of week 12 (from randomization) / End of Trial
