Treatment of Patients Over 64 Years of Age With Type 2 Diabetes Experience from nateglinide pooled database retrospective analysis

OBJECTIVE —To evaluate the impact of renal impairment (RI) (estimated creatinine clearance [Cl cr ] 2 ) and low baseline HbA 1c ( RESEARCH DESIGN AND METHODS —Retrospective subgroup analyses were performed on pooled data from all completed nateglinide studies (12 randomized, double blind trials and 1 open trial) in patients with type 2 diabetes. A total of 3,702 patients with ≥1 postbaseline safety evaluation received monotherapy with nateglinide ( n = 2,204), metformin ( n = 436), glyburide ( n = 293), or placebo ( n = 769). Efficacy (HbA 1c ) was evaluated in pooled data from four studies with similar design using 120 mg nateglinide ( n = 544) versus placebo ( n = 521). Evaluations were performed in the overall population and subgroups of patients over age 64 years. Specific considerations were given to RI, comorbidity, and baseline HbA 1c . RESULTS —Patients over age 64 years ( n = 1,170) represented 31.6% of the study population. Undiagnosed RI was common in the elderly with 83.4% of all patients being in this subgroup. Patients over 64 years with RI had a higher prevalence of cardio- and microvascular comorbidity compared with the overall population and all patients over age 64 years. Statistically significant HbA 1c reductions versus placebo were observed with nateglinide in patients over age 64 years and elderly with RI patients at study end point (−0.9% and −1.1% in each subgroup, P 1c . CONCLUSIONS —RI and comorbidity are common in patients over age 64 years with type 2 diabetes. Nateglinide was effective and well tolerated in all treated patients. In subgroups in which metformin and long-acting sulfonylureas must be used with caution, nateglinide had a low risk of adverse events and hypoglycemia.