Gliclazide and bedtime insulin are more efficient than insulin alone for type 2 diabetic patients with sulfonylurea secondary failure

Abstract

To determine the effects of combined therapy of gliclazide and bedtime insulin on glycemic control and C-peptide secretion, we studied 25 patients with type 2 diabetes and sulfonylurea secondary failure, aged 56.8 ± 8.3 years, with a duration of diabetes of 10.6 ± 6.6 years, fasting plasma glucose of 277.3 ± 64.6 mg/dl and a body mass index of 27.4 ± 4.8 kg/m 2 . Patients were submitted to three therapeutic regimens lasting 2 months each: 320 mg gliclazide (phase 1), 320 mg gliclazide and bedtime NPH insulin (phase 2), and insulin (phase 3). At the end of each period, glycemic and C-peptide curves in response to a mixed meal were determined. During combined therapy, there was a decrease in all glycemic curve values (P<0.01). Twelve patients (48%) reached fasting plasma glucose <140 mg/dl with a significant weight gain of 64.8 kg (43.1-98.8) vs 66.7 kg (42.8-101.4) (P<0.05), with no increase in C-peptide secretion or decrease in HbA1. CPeptide glucose score (C-peptide/glucose x 100) increased from 0.9 (0.2-2.1) to 1.3 (0.2-4.7) during combined therapy (P<0.01). Despite a 50% increase in insulin doses in phase 3 (12 U (9-30) vs 18 U (11-60); P<0.01) only 3 patients who responded to combined therapy maintained fasting plasma glucose <140 mg/dl (P<0.02). A tendency to a higher absolute increase in C-peptide (0.99 (0.15-2.5) vs 0.6 (0-2.15); P = 0.08) and C-peptide incremental area (2.47 (0.22-6.2) vs 1.2 (0-3.35); P = 0.07) was observed among responders. We conclude that combined therapy resulted in a better glucose response to a mixed meal than insulin alone and should be tried in type 2 diabetic patients before starting insulin monotherapy, despite difficulties in predicting the response.

Insulin therapy in type 2 diabetes: what is the evidence?

“…A total of 116 RCTs were selected by title or abstract by the first author. After reading the text, 38 articles were excluded because of follow up less than 2 months [5–7], pharmacokinetic/dynamic studies [8–12], too few patients [13–19], only hospitalized participants [20,21], an extension or a substudy of an RCT with no relevance to the topic of the review [22,23], being a substudy of an included RCT [24–26], oral agents added to insulin therapy [27,28], no RCT after all [29–31], only describing within‐group and not between‐group outcomes [32], pooled data of two trials [33], underpowered [34], comparing different time schedules [35], comparing patient‐ or physician‐driven regimens [36–38] and cost‐effectiveness analysis [39], comparison with troglitazone [40,41]. One trial did not include hypoglycaemia as an outcome measurement [42].…”

Controlled Porosity Solubility Modulated Osmotic Pump Tablets of Gliclazide

“…Prior research work revealed that it has good general tolerability, low incidence of hypoglycemia, and low rate of secondary failure (8,9). In addition, it has the potential for slowing the progression of diabetic retinopathy (10). For these reasons, gliclazide appears to be a drug of choice in long-term sulfonylurea therapy for the control of type 2 diabetes (7).…”

Drug utilization pattern in type II diabetes mellitus patients attending non-communicable disease clinic in a tertiary care hospital

“…13 Numerous studies have shown that a combination of insulin and sulfonylurea or metformin is more effective than insulin alone in the treatment of patients with Type II DM after secondary failure to oral drugs, leading to better glucose profiles and/or decreased insulin needs. 14,15 Hypertension (n=96) was the most common comorbid disease. Amlodipine (53%) was most often used, followed by atenolol (26.5%).…”