Characteristics associated with maintenance of mean A1C ORIGIN Trial Investigators  1 Collaborators, Affiliations Expand Collaborators ORIGIN Trial Investigators: Matthew C Riddle, Hertzel C Gerstein, Leanne Dyal, Markolf Hanefeld, Peter Johnston, Jeffrey L Probstfield, Ambady Ramachandran, Julio Rosenstock, Lars E Ryden, Giatgen A Spinas Affiliation 1 Corresponding author: Matthew C. Riddle, riddlem@ohsu.edu. PMID: 23656980 PMCID: PMC3781572 DOI: 10.2337/dc12-2238 Free PMC article Item in Clipboard

Abstract

Objective: To assess the success and baseline predictors of maintaining glycemic control for up to 5 years of therapy using basal insulin glargine or standard glycemic care in people with dysglycemia treated with zero or one oral glucose-lowering agents.

Research design and methods: Data from 12,537 participants in the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial were examined by baseline glycemic status (with or without type 2 diabetes) and by therapeutic approach (titrated insulin glargine or standard therapy) using an intention-to-treat analysis. Median values for fasting plasma glucose (FPG) and A1C and percentages with A1C<6.5% (48 mmol/mol) during randomized treatment were calculated. Factors independently associated with maintaining updated mean A1C<6.5% were analyzed with linear regression models.

Results: Median A1C in the whole population was 6.4% at baseline; at 5 years, it was 6.2% with glargine treatment and 6.5% with standard care. Of those with diabetes at baseline, 60% using glargine and 45% using standard care had A1C<6.5% at 5 years. Lack of diabetes and lower baseline A1C were independently associated with 5-year mean A1C<6.5%. Maintaining mean A1C<6.5% was more likely with glargine (odds ratio [OR] 2.98 [95% CI 2.67-3.32], P<0.001) than standard care after adjustment for other independent predictors.

Conclusions: Systematic intervention with basal insulin glargine or standard care early in the natural history of dysglycemia can maintain glycemic control near baseline levels for at least 5 years, whether diabetes is present at baseline or not. Keeping mean A1C<6.5% is more likely in people with lower baseline A1C and with the glargine-based regimen.

Trial registration: ClinicalTrials.gov NCT00069784.

Figures

Figure 1

Median FPG values and median A1C values at baseline, yearly during randomized treatment, and at the end of treatment are shown separately for participants without diabetes (A for FPG, C for A1C) and with diabetes (B for FPG, D for A1C) at baseline. The group assigned to use basal insulin glargine is shown by solid lines and solid circles, and the group assigned to standard care by broken lines and open circles. The numbers at the bottom of each panel show the number of observations included at each point in time.

Figure 2

Percentages of participants with A1C values A for <7.0%, C for <6.5%) and with diabetes (B for <7.0%, D for <6.5%) at baseline. The group assigned to use basal insulin glargine is shown by solid lines and solid circles, and the group assigned to standard care by broken lines and open circles.