A stepwise approach to insulin therapy in patients with type 2 diabetes mellitus and basal insulin treatment failure.

Abstract

OBJECTIVE:

To determine whether 1 or 2 preprandial injections before the meals of greatest glycemic impact can be as effective as 3 preprandial injections in patients with type 2 diabetes mellitus and basal insulin treatment failure.

METHODS:

This was an open-label, parallel-group, 1:1:1 randomized study of adults with type 2 diabetes mellitus on oral antidiabetic drugs with glycated hemoglobin (A1C) levels of 8.0% or greater. After a 14-week run-in with insulin glargine, patients with an A1C level greater than 7.0% were randomly assigned to 1, 2, or 3 time(s) daily insulin glulisine for 24 weeks. Changes in A1C from randomization to study end; percentage of patients achieving an A1C level less than 7.0%; changes in A1C, fasting glucose concentrations, and weight at individual study points; and safety (adverse events and hypoglycemia) were assessed throughout the study.

RESULTS:

Three hundred forty-three of 631 patients (54%) completing the run-in phase with insulin glargine were randomly assigned to treatment arms. During the randomization phase, A1C reductions with insulin glulisine once or twice daily were noninferior to insulin glulisine 3 times daily (confidence intervals: -0.39 to 0.36 and -0.30 to 0.43; P>.5 for both). However, more patients met the target A1C with 3 preprandial injections (46 [46%]) than with 2 injections (34 [33%]) or 1 injection (30 [30%]). Severe hypoglycemia occurred in twice as many patients receiving 3 preprandial injections (16%) compared with those receiving 2 injections (8%) and 1 injection (7%), but these differences did not reach significance.

CONCLUSION:

This study provides evidence that initiation of prandial insulin in a simplified stepwise approach is an effective alternative to the current routine 3 preprandial injection basal-bolus approach.

• Authors: Mayer B Davidson, Philip Raskin, Robert J Tanenberg, Aleksandra Vlajnic, Pricilla Hollander
• Journal: Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (Endocr Pract) 2011 May-Jun Vol. 17 Issue 3 Pg. 395-403 ISSN: 1934-2403 [Electronic] United States
• PMID: 21324825 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• Insulin, Long-Acting
• hemoglobin A1c protein, human
• insulin glulisine

Topics

• Adolescent
• Adult
• Aged
• Algorithms
• Blood Glucose (drug effects, metabolism)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Drug Administration Schedule
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Insulin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Insulin, Long-Acting
• Male
• Middle Aged
• Treatment Failure
• Young Adult