Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Rapilin 30 (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension Injection): Dose 0.6, 1.0, and 1.5 unit/mg/kg/day
Route of administration: Subcutaneous
Duration of treatment:
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c valueTimepoint: From baseline to end of 12 weeks and from baseline to end of 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in the FPG - Change in the post-prandial blood glucose - Proportion of subjects who achieve target HbA1c (= 7%) between the treatment groups - Safety and tolerability in terms of hypoglycemic episodes, AEs, clinical and laboratory assessments, and change in body weight - Anti-insulin antibodiesTimepoint: From baseline to end of 12 weeks and from baseline to end of 24 weeks | — |
Countries
India
Contacts
Public ContactMr. Rakesh Jain
Mankind Pharma Limited
Outcome results
None listed