A clinical trial Comparing the immunogenicity of two different brands of human Insulin for the treatment of diabetes.
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Type 1 & Type 2 DiabetesHealth Condition 3: E10- Type 1 diabetes mellitusHealth Condition 4: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2009/091/000862
- Lead Sponsor
- Spectrum Clinical Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
1.male and female patients suffering from type 1 or type 2 diabetes mellitus for at least 6 months before randomization.
2.negative screening assay for antibodies against insulin before the start of treatment.
3.Age 18-75 years.
4.Body Mass Index (BMI) ≤35 kg/m2.
5.informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug.
1.known hypersensitivity against insulin or any of the inactive components of the formulations
2.known extreme resistance to insulin (daily dose of more than 200 IU)
3.severe renal failure (NKF stage 4-5) or patients on hemodialysis
4.severe cardiac failure (NYHA III-IV)
5.myocardial infarction within the last 6 months before
randomization
6.unstable angina pectoris
7.stroke within the last 6 months before randomization
8.liver failure with ascites
9.severe peripheral vascular disease with ulceration or
amputation
10.cancer
11.concomitant treatment with corticosteroids (except stable dose of inhaled corticosteroids)
12.Concomitant treatment with immunosuppressive agents (e.g. cyclosporine A, methotrexate, etc.)
13.concomitant treatment with somatotropine
14.pregnancy or lactation period in female patients
15.severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
16.anamnestic or current alcohol abuse i.e. consumption of more than 10 units of alcohol per week or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals 250 ml of beer, 125 ml wine or 25 ml of spirits)
17.participation in another clinical trial within the last 12 weeks
18.legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
19.Unreliability or lack of cooperation
20.Lack of a possibility to attend the visits required by protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of newly developed anti-insulin antibodies during the double-blind treatment phase as determined by a screening assay and confirmed by a confirmatory assayTimepoint: Nil
- Secondary Outcome Measures
Name Time Method incidence of newly developed anti-insulin antibodies for the entire duration of treatment, <br/ ><br>- glycosylated hemoglobin (HbA1c) <br/ ><br>- dosage of insulin <br/ ><br>- incidence and severity of hypoglycemia, <br/ ><br>- Changes in weight.Timepoint: measured after 28 and 56 weeks of treatment