Health Condition 1: null- TYPE 2 DIABETES MELLITUS
Conditions
Interventions
Intervention1: GLARGINE, GLULISINE: Insulin Glargine and Insulin Glulisine administrated at pre-breakfast/dinner
Control Intervention1: Premixed Analogue Insulin 70/30: Premixed analogue insulin admin
Sponsors
India Diabetes Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Insulin naïve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months 2. Both men and women of age more than or equal to 18 and less than or equal to 65 years 3. Have an HbA1c more than or equal to 7.5% and less than or equal to 10.5% with fasting blood glucose more than or equal to 150 mg/dl and/or Postprandial blood glucose more than or equal to 200 mg/dl 4. Body mass index less than or equal to 40 kg/m2 5. Have given written informed consent to participate in this study in accordance with local regulations 6. Subject must have access to telephone for calling into the clinical center as part of test product compliance
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. BMI more than 40 kg/m2 3. Subject is being treated for severe active infection of any type 4. Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study 5. Planned surgery in the next 6 months 6. Any event forecasted to require a temporary need to switch to insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DMTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-point self-monitored blood glucose (SMBG) profilesTimepoint: 24 weeks;Blood pressureTimepoint: 24 weeks;Body Mass IndexTimepoint: 24 weeks;Fasting plasma glucoseTimepoint: 24 weeks;Insulin DoseTimepoint: 24 weeks;Overall adverse eventsTimepoint: 24 weeks;Percentage of participants with HbA1c less than 7%Timepoint: 24 weeks;Postprandial glucoseTimepoint: 24 weeks;Severe HypoglycemiaTimepoint: 24 weeks;Symptomatic HypoglycemiaTimepoint: 24 weeks;WeightTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr K Satheesh
Dr.A.Ramachandrans Diabetes Hospitals
Outcome results
None listed