A Study on Comparison of Glargine Plus Glulisine With Premixed Insulin in Type 2 Diabetes Patients
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal
Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2
Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The
primary outcome measures will be 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 T2DM. The secondary outcomes is to compare the following in the two arms
between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point
self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%,
Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight,
BMI and Blood pressure.
Phase:
Phase 4
Details
Lead Sponsor:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals