| Experimental Group |
Basalplus insulin therapy |
Basal-plus insulin regimen
At the end of the clamp visit, participants received a meal at the study site and were monitored to avoid hypoglycaemia. Based on blood glucose values 4 hours after the clamp, basal-plus regimen was initiated. Insulin Glargine was initiated at bedtime, starting at 0.3IU/Kg/day (HbA1c > 63.9mmol/mol) and at 0.4IU/kg if (HbA1c > 74.9mmol/mol). Participants were given a glucose meter, test strips, a lancing device, lancets, a pen of insulin Glargine, self-monitoring blood glucose (SMBG) form and educated on their use. Four point SMBG profiles (before breakfast, 2-hours after lunch, before dinner and at bedtime) were performed every 2 days during the first week, then twice per week till the end of the study. Participants were educated on signs of hypoglycemia and how to manage this complication. Our treatment goals established according the recommendations of the ADA were: Fasting blood glucose (FBG): 70-130mg/dl (3.9-7.2mmol/L); Post prandial blood glucose (2 hours after a meal): < 180mg/dl (<10,0mmol/L) and Avoid hypoglycemia.
Following the results of FBG from the SMBG, basal insulin dose was adjusted every 48 hours during the first week. Once FBG target was achieved, a single dose of pre-meal insulin Aspart was added to the meal with the largest post prandial excursion and adjusted to give post prandial blood glucose values below 10.0mmol/l. Follow-up visits were planned on days 15 to 30 after the start of the basal-plus regimen to monitor adherence, adverse events and to avoid loss to follow-up. Maximum daily insulin dose needed to attain optimal glycaemic control was maintained for the subsequent five weeks. Daily insulin dose was then gradually decreased by 0.05 IU/kg every two days till the end of the eighth week.
On day 59, the basal-plus insulin regimen was stopped by the attending physician. Blood samples were collected for HbA1c, serum creatinine and lipid profile measurements. The next day, the patients came fasting were the second hyperinulinaemic-euglycaemic clamp was performed.
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8 weeks |
Newly diagnosed T2DM patients had an 8-week course of basal-plus insulin therapy which was then discontinued. Weekly 4-point glycemic profiles were done. Insulin sensitivity, using the hyperinsulinemic euglycemic clamp was assessed at baseline and after the basal-plus insulin intervention. HbA1c and lipid profile were also assessed. Early remission was defined as HbA1c < 48 mmol/mol without treatment for at least 12 weeks. |
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