A comparative safety and efficacy of insulin analogue glargine in Type-1 diabetes patients.
- Conditions
- Type-1 Diabetes.
- Registration Number
- CTRI/2011/11/002173
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
**Primary Objectivexml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /**
To determine whether Glaritus® is non-inferior to Lantus® in glycemic control or not.
**Secondary Objectives**
- To compare the change in the blood glucose levels, from baseline to end of trial, between both arms.
- To compare the change in glargine dose, from baseline to end of trial, between both arms.
- To compare the immunogenic response to glargine in both arms.
- To compare the number of episodes of hypoglycemia between both arms.
- To assess and compare subjects safety between both arms.
**Primary Endpoint**
Change in HbA1c from baseline to end of trial between Glaritus® arm and Lantus® arm.
**Secondary Endpoints**
- Change in the Fasting Blood Glucose from baseline to end of trial between Glaritus® and Lantus®.
- The change in the glargine dose between the Glaritus® arm and Lantus® arm after 12 weeks (end of trial). Subjects will be grouped as:
a) No change in glargine dose (± 10% of the dose required at baseline)
b) >10% increase in glargine dose
c) >10% decrease in glargine dose
- The change in the immunogenic response (measured as percentage change in serum xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /AIA), from baseline to end of trial in both arms.
- **Safety:** Safety assessments include adverse events (including hypoglycemia events), serious adverse events, laboratory test results, ECG findings, vital signs and physical examination findings.
Summary of Trial DesignProspective, 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)
xml:namespace prefix = v ns = "urn:schemas-microsoft-com:vml" /xml:namespace prefix = w ns = "urn:schemas-microsoft-com:office:word" /6. Visit 6/ End of week 12 (from randomization) / End of Trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 322
- 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.
- Subjects with glycosylated hemoglobin (HbA1c) levels between 8 and 10%.
- Subjects with body mass index (BMI) 18.0 to 38.0 kg/m2.
- Subjects who understand nature of trial & provide written informed consent.
- Subjects who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
- 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).
- Ability to use the self glucose-monitoring device and to self administer insulin.
- 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.
- A subject with impaired renal function, where serum creatinine 2.0 mg/dl and/or BUN 30 mg/dl.
- A subject with serum AIA result 0.95 index value (i.e., “Borderline†or “Positiveâ€).
- A subject who is Hepatitis B or C or HIV positive.
- 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.
- A Subject whose requirement for total daily dose of insulin is 1.4 units/kg.
- A subject with history or evidence of allergy to insulin preparations.
- A subject with history or evidence of recurrent severe hypoglycemia.
- 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.
- A subject who has received an oral hypoglycaemic agent within 4 weeks prior to screening.
- 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.
- A subject who has undergone pancreatectomy or pancreas/islet cell transplant.
- A subject who has been treated with other investigational agent or devices within the previous 30 days.
- A subject who is unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
- 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.
- A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c Baseline | End of trial
- Secondary Outcome Measures
Name Time Method Safety Through out the trial Change in dose between 2 arms. Between randomization to end of trial.
Trial Locations
- Locations (12)
BRIDE,Bharati Hospital
🇮🇳Karnal, HARYANA, India
Dothim Clinic
🇮🇳Ludhiana, PUNJAB, India
Endocrine and Diabetes Center
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Fortis Hospital
🇮🇳Chandigarh, CHANDIGARH, India
Jnana Sanjeevini Medical Center
🇮🇳Bangalore, KARNATAKA, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Kolkata Diabetes and Endocrine Foundation
🇮🇳Kolkata, WEST BENGAL, India
Orange Diabetes Specialty Clinic
🇮🇳Pune, MAHARASHTRA, India
Osmania General Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Sais Institute Of Endocrinology
🇮🇳Hyderabad, ANDHRA PRADESH, India
Scroll for more (2 remaining)BRIDE,Bharati Hospital🇮🇳Karnal, HARYANA, IndiaDr Sanjay KalraPrincipal investigator9896048555brideknl@gmail.com