A clinical trial to study safety and efficacy of two drugs Insugen® R and Insugen® N with Actrapid® and Insulatard® in Patients with Type 1 Diabetes Mellitus.
- Conditions
- Health Condition 1: null- Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2010/091/000627
- Lead Sponsor
- Biocon SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 286
1. Provide written informed consent
2. Patients between the ages of 18 to 80 years
3. T1DM patients diagnosed with in the last 1 year.
4. Patients on basal-bolus insulin therapy
5. Body mass index of 18.5 to 34.99 kg/m2
6. Stable weight
7. Glycosylated haemoglobin of less than or equal to 11.0 percentage
8. Ability and willingness to comply with the protocol
1.History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products
2.Significant history of atopy or allergic drug reactions
3.Use of insulin pump therapy
4.Moderate insulin resistance
5.A clinically significant laboratory abnormality on the basis of which the Investigator advises against study inclusion
6.Clinically significant disease, except for well-controlled hypertension, hyperlipidaemia and thyroid disorders which as per the investigator makes the patient unsafe to be included in the study
7.Complications of abnormal glucose control and secondary complications of diabetes
8.An electrocardiogram abnormality considered clinically significant by the Investigator
9.History of drug or alcohol dependence or abuse within 6 months before Screening
10.Use of medications that can affect sugar control
11.Any electively planned surgery requiring hospitalization
12.Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential (any woman who is not surgically sterile or more than 2 years post menopause) must agree to use a reliable method of contraception (e.g., double-barrier, tubal ligation, or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome
13.Hematological disorders
14.Receipt of another investigational drug within 6 weeks before Screening or within 5 half-lives of the drug, whichever is longer, or scheduled treatment of another investigational drug during the current study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groupsTimepoint: From baseline to Week 24 and 48;Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groupsTimepoint: From baseline to Week 24 and 48
- Secondary Outcome Measures
Name Time Method Diabetes Treatment Satisfaction QuestionnaireTimepoint: Between baseline and week 24;Efficacy parameters including HbA1c, FPG, 7-PCBG and insulin doseTimepoint: Between baseline and week 24;Partial correlation between allergic reactions and insulin antibodies, HbA1c and insulin antibodies, insulin dose and insulin antibodiesTimepoint: Between baseline and week 24;Safety parameters including Local and systemic reactions, hypoglycaemic events per 100 patients and other AEâ??sTimepoint: Between baseline, week 24 and 48