Comparison of two insulin (Glaritus and Lantus) in patient with Type II Diabetes
- Conditions
- Health Condition 1: null- Type II Diabetes
- Registration Number
- CTRI/2015/05/005808
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
subject will be eligible for enrolment if, all of the following apply at the
time of screening:
1. Male or Female Subjects >= 18 and <= 55 years of age
2. Subjects with body mass index (BMI) >=18.0 and <= 38.0 kg/m2
3. Subjects who have been diagnosed with T2DM.
4. Subjects with HbA1c levels >= 8% and <= 10%
5. Subjects who are insulin naïve or may have received insulin for short
term (<=2 weeks) only and >=6 months prior to enrolment.
6. Subjects who are inadequately controlled by one or more OHAs and
according to investigator needs glargine treatment as standard of care
7. Subjects who are co-operative, reliable, and agree to have regular
injections of insulin and are willing to comply with protocol
procedures.
8. Ability to use the self-glucose-monitoring device and to selfadminister
insulin and willing to record the daily FBG values and the
insulin dose in a subject diary
9. Subjects who understand the nature of trial and provide written
informed consent for the trial and the audio visual recording of the
informed consent process
The subjects who meet, any of the following criteria at screening will not be
eligible for enrolment in the study:
1. Women of child-bearing potential who are pregnant or lactating or not
following adequate contraceptive measures.
2. Subjects with type 1 diabetes mellitus
3. Secondary diabetes or maturity-onset diabetes
4. History or evidence of allergy to insulin preparations
5. History or evidence of recurrent hypoglycemia
6. Currently receiving or has received any insulin therapy for more than
2 weeks within 6 months of enrolment.
7. 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.
8. History or evidence of nephropathy and/or neuropathy, significant
cardiovascular disease, active severe proliferative retinopathy, renal
dysfunction, hepatic dysfunction, any malignancy, thyroid
dysfunction, alcohol or drug abuse or any other medical condition that
in the opinion of Investigator can interfere with the study treatment.
9. History of Hepatitis B or C or human immunodeficiency virus (HIV)
positive status
10. Undergone pancreatectomy or pancreas/islet cell transplant
11. A subject who has been treated with other investigational agent or
devices within the previous 30 days.
12. Unlikely to comply with the study protocol e.g. unable to return
periodically for subsequent visits
13. 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 Percentage change in AIA titer to glargine in Glaritus® and Lantus® <br/ ><br>treatment arms from baseline to 6 monthsTimepoint: Screening, Month 3, month 6
- Secondary Outcome Measures
Name Time Method Percentage change in AIA titer to glargine in Glaritus® treatment arm <br/ ><br>from baseline to 12 monthsTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;Change in glycosylated haemoglobin (HbA1c) (%) from baseline to 6 <br/ ><br>months in both treatment armsTimepoint: baseline, 3 months, 6 months;Exploratory Endpoint: <br/ ><br>Change in HbA1c from baseline to 12 months in Glaritus® treatment <br/ ><br>armTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;Safety assessments including adverse events (AEs) (including <br/ ><br>hypoglycemia events), serious adverse events (SAEs), laboratory test <br/ ><br>results, electrocardiogram (ECG) findings, vital signs and physical <br/ ><br>examination findingsTimepoint: throughout study