A comparative study of two different formulations of Insult Aspart protamine suspension in adult patients of Type 2 diabetes

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2024/07/071182
• Lead Sponsor: Mankind Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female patients between the ages of 18 to 65 years, both ages inclusive, who have provided written informed consent for participation in the study and willing to comply with study procedures.

2. Patients with an established diagnosis of T2DM and a duration of diabetes mellitus of at least 6 months at screening visit.

3. HbA1c between 7.5% - 10.0% (both values inclusive).

4. BMI of = 40.0 kg/m2.

5. Patients treated with premix human insulin (one or more insulin injections) for at least 3 months prior to the screening visit

6. Insulin Aspart/Insulin Aspart mixes’ naïve patients

7. Current treatment with up to 3 OADs/without OADs; in case of patients on OADs unchanged dosing for at least 3 months prior to the screening visit.

8. Female patients who are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to

continue using a reliable method of birth control.

9. Willingness and ability to self-inject insulin (2 injections daily), perform self-monitoring of blood glucose (SMBG) testing, and keep record in the patient diary.

Exclusion Criteria

1. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the day of screening.

2. Known or suspected hypersensitivity to insulin or related product(s).

3. Patients on insulin analogs (other than premix human insulin).

4. Patients with any other clinically significant disease(s) which, in the opinion of the Investigator could compromise the patient’s safety, the patient’s involvement in the study or overall interpretation of the study data.

5. Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New

York Heart Association, within 6 months prior to screening.

6. Impaired liver function, defined as alanine transaminase = 2.5 times upper limit of normal.

7. Patients who have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).

8. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.

9. Patients who have active proliferative retinopathy or macular edema.

10. Known/screening seropositive patients of human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus (HCV).

11. Women of child bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and at least 1 week after the last visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified