Improvement of Glycemic Control in Subjects With Poorly Controlled Type 2 Diabetes

Abstract

OBJECTIVE -Large prospective studies have demonstrated that optimum glycemic control is not routinely achieved in clinical practice. Barriers to optimal insulin therapy include hypoglycemia, weight gain, and suboptimal initiation and dose titration. This study compared two treatment algorithms for insulin glargine initiation and titration: algorithm 1 (investigator led) versus algorithm 2 (performed by study subjects). RESEARCH DESIGN AND METHODS-A prospective, multicenter (n ϭ 611), multinational (n ϭ 59), open-label, 24-week randomized trial in 4,961 (algorithm 1, n ϭ 2,493; algorithm 2, n ϭ 2,468) suboptimally controlled type 2 diabetic subjects.RESULTS -At baseline, mean diabetes duration was 12.3 Ϯ 7.2 years, and 72% of subjects were pretreated with insulin. At end point, there was no significant difference in the incidence of severe hypoglycemia between algorithms 1 and 2 (0.9 vs. 1.1%). There was a significant reduction in HbA 1c from 8.9 Ϯ 1.3 to 7.8 Ϯ 1.2%, with a greater decrease (P Ͻ 0.001) with algorithm 2 (Ϫ1.22%) versus algorithm 1 (Ϫ1.08%). Fasting blood glucose decreased from 170 to 110 mg/dl, with a greater decrease (P Ͻ 0.001) with algorithm 2 (Ϫ62 mg/dl) versus algorithm 1 (Ϫ57 mg/dl). Mean basal insulin dose increased from 22.9 Ϯ 15.5 to 43.0 Ϯ 25.5 IU, with a significant difference (P Ͻ 0.003) between algorithm 2 (21.6 IU) and algorithm 1 (18.7 IU).CONCLUSIONS -Glargine is safe and effective in improving glycemic control in a large, diverse population with longstanding type 2 diabetes. A simple subject-administered titration algorithm conferred significantly improved glycemic control with a low incidence of severe hypoglycemia compared with physician-managed titration.

Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

“…74,76,88 For example, the addition of 1-2 units (or, in those already on higher doses, increments of 5-10%) to the daily dose once or twice weekly if the fasting glucose levels are above the preagreed target is a reasonable approach. 89 As the target is neared, dosage adjustments should be more modest and occur less frequently. Downward adjustment is advisable if any hypoglycemia occurs.…”

Initiate Insulin by Aggressive Titration and Education (INITIATE)

“…In studies where an A1C of ϳ7.0% was achieved, the insulin dose was aggressively titrated by daily measurement of FPG and frequent self-adjustment of insulin dose (4,6,9). Recent comparison of titration algorithms in 4,961 patients with type 2 diabetes showed that a simple subject-administered titration conferred significantly improved glycemic control with a low incidence of severe hypoglycemia compared with physician-managed titration (10).…”

Diabetes Control Among Hispanics in the Action to Control Cardiovascular Risk in Diabetes Trial

“…8 Insulin therapy at baseline reflecting a progressive decline of beta cell function, 23 was significantly linked with poorer *Glycated hemoglobin goal refers to <6.5 for the intensive arm and 7-7.9, inclusive, for the standard arm † Ever had a measured hemoglobin of >6.5/>7.9 among those who first achieved goal in their respective treatment arms ‡ Time to first glycated hemoglobin goal achievement; if <6.5/<7.9 at baseline, time to achievement = 0 days and cultural competence beyond language-consonance between clinical staff and study participants 8,25 were not the focus of the ACCORD trial and detailed measures were not collected. These factors could influence self-care such as glucose self-monitoring, 26 life style 27 and willingness to have therapy intensified. The importance of self-care in diabetes management is consistent with our observation that the differences in achieving glycated hemoglobin goal were more magnified in the intensive treatment arm compared to the standard arm of the ACCORD trial.…”