Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Insuquick (Recombinant insulin Aspart): Dose 0.5 to 1.0 unit/kg/day. Route of administration: Subcutaneous (S.C), Duration of treatment 24 weeks, manufactured by BioGenomics Limited
Co
Sponsors
BioGenomics Limited
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent. BMI less than or equal to 45 kg/m2. Have T2DM for more than or equal to 1 year. Treated for more than 90 days prior to screening with multiple daily injections. Current treatment with/without OADs. Willingness and ability to self inject insulin, perform SMPG and keep record in patient diary. HbA1c between 7.5% and 10%. Both male and female with child bearing potential must use highly effective methods of contraception throughout the trial and for 07 days after last IP dose.
Exclusion criteria
Exclusion criteria: Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory test, any other study procedures and study restrictions. Haveing any other condition that precludes the subject from following and completing the protocol. Have been diagnosed at any time with T1DM or latent autoimmune diabetes in adults. Have hypoglycemia unawareness as judged by the investigator. History or evidence of allergy to insulin preparations and their excipients. Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. History of renal transplantation. Currently receiving renal dialysis. Have active or untreated malignancy. Have cardiovascular diseases. History of bariatric surgery, gastric bypass surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Primary objective: 1.To assess risk of hypoglycemia in adult subjects with T2DM who will be administered Insulin Aspart. B. Secondary objective: 1.To assess adverse events (AEs) and other safety parameters in adult subjects with T2DM. 2.To assess efficacy of Insulin Aspart in adult subjects with T2DM. Timepoint: 1.Incidence of hypoglycemia, nocturnal hypoglycemia and number of TEAEs [Baseline through Week 24]. 2.Change from baseline to week 12 and 24 in HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess adverse events (AEs) and other safety parameters in adult subjects with T2DM. 2. To assess efficacy of Insulin Aspart in adult subjects with T2DM.Timepoint: 1. Rate (events/subject/year) of hypoglycemia [Baseline through Week 24]. 2. Incidence and rate of severe hypoglycemic events [Baseline through Week 24]. 3. Incidence and rate of nocturnal hypoglycemia [Baseline through Week 24]. 4. Incidence and rate of all documented symptomatic hypoglycemia [Baseline through Week 24]. 5. Incidence and rate of all documented asymptomatic hypoglycemia [Baseline through Week 24]. 6. Incidence and rate of all documented hypoglycemic events [Baseline through Week 24]. 7. Incidence and rate of nocturnal and all documented hypoglycemic events [Baseline through Week 24]. 8. Numbers of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) during the study [Baseline through Week 24] Efficacy endpoints: 9. Change from baseline to week 12 and 24 in HbA1c. | — |
Countries
India
Contacts
Public ContactSneha Dongre
BioGenomics Limited
Outcome results
None listed