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

• Conditions: Type 1 Diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-018354-12-DE
• Lead Sponsor: Biocon S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-11
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

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 insulin treatment within 6 months after diagnosis (confirmed by interview with patient)
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 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

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:
a. Retinopathy: moderate to severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy of
any severity or history of treatment with laser surgery/vitrectomy within 6 months of the Screening visit
b. Nephropathy: Proteinuria =1+ by urine dipstick in the absence of infection or vaginal contamination and/or
serum creatinine =1.5 times of upper limit of reference range, one (1) re-test is permitted within the Screening
timeline, if required; history of renal transplant
c. Neuropathy: History or finding of severe form of sensorimotor, cardiac, gastrointestinal, or genitourinary
autonomic neuropathy
d. Peripheral vascular disease (PVD): Severe PVD that has resulted in amputation, chronic foot ulcer,
claudication on walking <200 metres, or absent pulses
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
(any woman who is not surgically sterile or > 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
18. Impaired

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified