Titration and optimization trial for the initiation of insulin glargine 100 U/mL in patients with inadequately controlled type 2 diabetes on oral antidiabetic drugs.
For patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, addition of basal insulin is recommended, but titration and optimization of basal insulin therapy in primary care is not well understood. We conducted an observational trial in 2470 patients with T2DM who initiated insulin glargine 100 U/L (Gla-100) on top of oral antidiabetic drugs. Physicians were free to choose either a "Davies," "Fritsche" or "individual" titration algorithm. We found that fasting blood glucose (FBG) and glycated haemoglobin (HbA1c) levels were effectively reduced by Gla-100; 65.9% of patients achieved the primary endpoint (FBG ≤6.1 mmol/L (110 mg/dL) or an individual HbA1c target). There were no significant differences in efficacy and safety between the algorithms used. The mean FBG decreased by 3.2 mmol/L (59 mg/dL) over 12 months, while the mean HbA1c decreased by 15.3 mmol/mol (1.4%)%. From a starting dose of 11.7 U/d, the Gla-100 dosage was 22.8 U/d at 12 months, with similar values in each group. Rates of hypoglycaemia were low and did not differ by titration algorithm. We conclude that Gla-100 was effective at reducing FBG and HbA1c, independent of the titration algorithm, but observed that algorithms were inconsistently applied in clinical practice.
['Seufert|Jochen|J|0000-0001-5654-7310', 'Fritsche|Andreas|A|', 'Pscherer|Stefan|S|', 'Anderten|Helmut|H|', 'Borck|Anja|A|', 'Pegelow|Katrin|K|', 'Bramlage|Peter|P|', 'Pfohl|Martin|M|']
D000284:Administration, Oral D000368:Aged D000465:Algorithms D001786:Blood Glucose D002138:Calibration D003924:Diabetes Mellitus, Type 2 D004305:Dose-Response Relationship, Drug D054796:Drug Dosage Calculations D004359:Drug Therapy, Combination D005260:Female D005500:Follow-Up Studies D006801:Humans D007004:Hypoglycemic Agents D000069036:Insulin Glargine D008297:Male D008875:Middle Aged D017211:Treatment Failure
insulin glargine basal titration algorithm hypoglycaemia basal insulin-supported oral therapy