A Randomized, Active Controlled, Parallel Group, Multicentre, Two-Phase, Open-Label Study Comparing the Safety and Immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in Patients with Type 1 Diabetes Mellitus - ND
- Conditions
- Diabetes Mellitus Type 1MedDRA version: 9.1Level: LLTClassification code 10045228
- Registration Number
- EUCTR2010-018354-12-IT
- Lead Sponsor
- BIOCON S A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 286
1.Provide written informed consent 2.Male and female patients between the ages of 18 to 80 years, inclusive 3.Patient must have been diagnosed with T1DM before 40 years of age and must have been on treatment with insulin for at least one year (confirmed by interview with the patient). Patients should have a fasting plasma C-peptide ?0.2 pmol/mL (?0.6 ng/mL or ?0.2 nmol/L) and/or a history of initiation of insulin treatment within 6 months after diagnosis 4.At least 3 months on basal-bolus insulin therapy before enrolment requiring 3 or more daily injections 5.Body mass index of 18.5 to 34.99 kg/m2, inclusive 6.Stable weight with no more than 5 kg gain or loss within 3 months of Screening (obtained by patient history) 7.Glycosylated haemoglobin (HbA1c) = 11.0% at Screening. One (1) re-test is permitted within the Screening timeline, if required. 8.Ability and willingness to perform blood glucose profiles using blood glucose meter at home during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products 2.A clinically significant abnormality (including laboratory values) at Screening, on the basis of which the Investigator advises against study inclusion 3.An electrocardiogram (ECG) abnormality at Screening considered clinically significant by the Investigator 4.Use of insulin pump therapy in the past 2 months before Screening 5.Moderate insulin resistance defined as requiring insulin of 1.4 IU/kg/day 6.Significant history of atopy or allergic drug reactions 7.Clinically significant major organ disease before Screening, except for well-controlled and stable conditions such as essential hypertension (blood pressure >130/80 mmHg), well controlled hyperlipidaemia, and thyroid disorders for at least 3 months before Screening. 8.Knowledge of secondary complications of diabetes. 9.Unstable coronary artery disease (unstable angina, myocardial infarction within the preceding 6 months), heart failure (New York Heart Association Grade 2 or higher), history of stroke, or transient ischemic attack within the preceding 6 months 10.History of drug or alcohol dependence or abuse within 6 months before Screening 11.Current use of systemic or inhaled glucocorticoids or other drugs which may affect glycaemic control 12.Treatment with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks before Screening or during the study 13.The use of prohibited concomitant medications, including oral hypoglycaemic agents; monoamine oxidase (MAO) inhibitors; Beta blockers; salicylates >300 mg/day or chronic usage requiring uninterrupted administration for >14 days during the study; anabolic steroids; diltiazem; niacin; isoniazid; epinephrine; thiazide diuretics if >25 mg/day; and loop diuretics. 14.History of 2 or more episodes of hypoglycaemia requiring assistance by another person to administer glucose or glucagon (severe hypoglycaemia) within 6 months before Screening 15.Any hospitalisation or emergency department visit due to poor diabetes control within 6 months before Screening 16.Any electively planned surgery requiring hospitalisation 17.Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential must agree to use a reliable method of contraception throughout the study period. Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome 18. Impaired hepatic function (alanine transaminase [ALT] or aspartate aminotranferase [AST] value > 2 times the upper limit of the reference range and/or serum bilirubin >1.5 times the upper limit of the reference range at the Screening visit) 19.Impaired renal function (serum creatinine =1.5 times of upper limit of the reference range at Screening) or chronic kidney disease (estimated glomerular filtration rate < 60 mL/min/1.73m2) 20.Haemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c 21.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 22.Any patient who in the estimation of the Investigator does not show necessary compliance to participate in the trial and comply with necessary trial requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method