Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Recombinant insulin aspart: Dose 0.5 and 1.0 unit/kg/day
Route of administration Subcutaneous(S.C.)
Duration of treatment 24 weeks
Manufactured by BioGenomics Limited.
Control Interven
Sponsors
BioGenomics Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included in the study: 1.Type 2 DM patients willing to give written informed consent and willing to take a maximum of 4 injections daily. 2.Patients with T2DM, diagnosed since at least 6 months, who have been treated with premix human insulin (one or more insulin injections), who are insulin aspart/insulin aspart mixesââ?¬• naive, daily for ïâ??³3 months prior to the screening visit. 3.Current treatment with/without OADs; in case of patients on OADs unchanged dosing for ïâ??³3 months prior to the screening visit. 4.HbA1c between 7.5% -10.0%, both inclusive. 5.Both sexes aged between 18 to 65 years. 6.Body Mass Index (BMI) ââ?°Â¥18kg/m2and ââ?°Â¤ 40 kg/m2. 7.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. 8.Willingness and ability to self-inject insulin, perform SMPG, and keep record in the patient diary.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1.Known or suspected hypersensitivity to insulin or related product(s). 2.Previous participation in this trial (participation is defined as randomization). 3.Patients on insulin analogs (other than premix human insulin). 4.Patients who have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening or are likely to simultaneously participate in another therapeutic clinical study. 5.Patients with any other clinically significant disease(s) which, in the opinion of the Investigator could compromise the patientââ?¬•s safety, the patientââ?¬•s involvement in the study or overall interpretation of the trial data. 6.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. 7.Impaired liver function, defined as alanine transaminase ââ?°Â¥2.5 times upper limit of normal. 8.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). 9.Patients who are doubtful to comply with study procedures for mental, psychological or social reasons. 10.Patients who have active proliferative retinopathy or macular edema. 11.Known/screening seropositive patients of HIV or HBV or HCV. 12.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 |
|---|---|
| To compare the efficacy of recombinant insulin aspart (manufactured by BGL) with NovoRapidÃ?® (manufactured by Novo Nordisk) by measuring Mean change in glycated haemoglobin (A1C) from Baseline to end of 12 weeks and from Baseline to end of 24 weeksTimepoint: From baseline to end of 12 weeks and from baseline to end of 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the fasting plasma glucose from baseline to end of 12 weeks and from baseline to end of 24 weeks Mean change in the post-prandial plasma glucose (after standard meal challenge) from baseline to end of 12 weeks and from baseline to end of 24 weeks Proportion of patients who achieve target A1C (7%) between the treatment groups at the end of 12 weeks and 24weeks. Timepoint: From baseline to end of 12 weeks and from baseline to end of 24 weeks. | — |
Countries
India
Contacts
Public ContactDr Dilip Javalkar
BioGenomics Limited.
Outcome results
None listed