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.

Phase 3

• Conditions: Health Condition 1: null- Type 1 Diabetes Mellitus

• Registration Number: CTRI/2009/091/000098
• Lead Sponsor: Biocon S.A. Fid Borruat Sarl, Sous Maichereux 20 Case postale 2027 CH-2800, Delemont, Switzerland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 274

Inclusion Criteria

1. Provide written informed consent
2. Male and female patients between the ages of 18-80 years inclusive
3. Established diagnosis of T1DM for at least 1-year as per revised WHO criteria. Diagnosis of T1DM will be based on fasting plasma C-peptide 0.2 pmol/ml and / or history of initiation of insulin treatment within 6 months after diagnosis
4. Body mass index of 18.5-34.99 kg/m2 inclusive
5. Stable weight with no more than 5 kg gain or loss within 3 months of screening (obtained by patient history)
6. Glycosylated hemoglobin (HbA1c) ≤ 11.0% inclusive at screening
7. On stable daily doses (10% daily) of insulin or an insulin analogue for at least 3 months that requires two or more daily injections
8. Ability and willingness to perform blood glucose profiles using blood glucose meter at home during the study. Ability to perform blood glucose will be based on a completed 7-point glucose profile as described in Appendix C obtained over a single 24-hour period during the screening phase

Exclusion Criteria

1. History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products
2. Patient with a clinically significant abnormality (including laboratory values) at screening, on the basis of which the Investigator advises against study inclusion
3. An ECG abnormality at screening considered clinically significant by the Investigator
4. Use of insulin pump therapy in the past 2 months prior to screening
5. 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 prior to screening, except for well-controlled and stable conditions such as essential hypertension (blood pressure <130/80 mmHg), and well controlled hyperlipidemia for at least 3 months prior to screening
8. Evidence of severe secondary complications of diabetes (e.g. active proliferative retinopathy, severe peripheral vascular disease, nephropathy, neuropathy or diabetic retinopathy treated with laser coagulation / vitrectomy within 6 months of the screening visit)
9. Unstable coronary artery disease (unstable angina, myocardial infarction within the preceding 6 months), heart failure (NYHA Grade 2 or higher), history of stroke within the preceding 6 months
10. History of drug or alcohol dependence or abuse within 6 months prior to screening
11. Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control
12. Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study
13. History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening
14. Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening
15. Any electively planned surgery requiring hospitalization
16. Pregnancy, lactation, or planned pregnancy during the study duration. Women of childbearing potential (any women who is not surgically sterile or > 2 years post menopause) must give consent for using 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, but followed for pregnancy outcome
17. Impaired hepatic function (ALT or AST value greater than 2 times of upper limit of normal and/or serum bilirubin >1.5 times of upper limit of reference range at the screening visit)
18. Impaired renal function (serum creatinine &#8805;1.5 times of upper limit of reference range at screening)
19. Hemoglobinopathies, hemolytic anemia, anemia of chronic disease, or any factor affecting the measurement of HbA1c
20. The patient has received another investigational drug within 6 weeks prior to screening or within 5 half-lives of the drug, whichever is longer, or is scheduled for treatment with another investigational drug during the current study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified