OBJECTIVES: To compare the safety and efficacy of adding insulin glargine or neutral protamine Hagedorn (NPH) insulin to existing oral antidiabetic drug (OAD) regimens in adults with type 2 diabetes mellitus. DESIGN: Pooled analysis of data from five randomized controlled trials with similar designs. SETTING:Three hundred forty-two centers in more than 30 countries worldwide. PARTICIPANTS: Randomly selected individuals aged ≤ 80 with a body mass index ≤ 40 kg/m(2) and a glycosylated hemoglobin (HbA1c) level of 7.5% to 12.0%. MEASUREMENTS: Fixed- and random-effects models were used to compare outcomes after 24 or 28 weeks of treatment (insulin glargine, n = 1,441; NPH insulin, n = 1,254) according to age (≥65, n = 604 vs < 65, n = 2,091) and age based on treatment (e.g., ≥65 receiving insulin glargine vs NPH insulin). Outcomes included change in HbA1c, fasting blood glucose (FBG), insulin dose, and hypoglycemia incidence and event rates. RESULTS: At end point, participants aged 65 and older receivinginsulin glargine had greater reductions in HbA1c and FBG than those receiving similar doses of NPH insulin. In contrast, for participants younger than 65, there were no statistically significant differences in reductions in HbA1c or FBG between insulin glargine and NPH insulin. Daytime hypoglycemia rates were similar in all groups, although the rates of nocturnal symptomatic and severe hypoglycemia were lower with insulin glargine than NPH insulin. CONCLUSION: Addition of insulin glargine to oral antidiabetic drugs in older adults with poor glycemic control may have modestly better glycemic benefits than adding NPH insulin, with low risk of hypoglycemia.
RCT Entities:
OBJECTIVES: To compare the safety and efficacy of adding insulinglargine or neutral protamine Hagedorn (NPH) insulin to existing oral antidiabetic drug (OAD) regimens in adults with type 2 diabetes mellitus. DESIGN: Pooled analysis of data from five randomized controlled trials with similar designs. SETTING: Three hundred forty-two centers in more than 30 countries worldwide. PARTICIPANTS: Randomly selected individuals aged ≤ 80 with a body mass index ≤ 40 kg/m(2) and a glycosylated hemoglobin (HbA1c) level of 7.5% to 12.0%. MEASUREMENTS: Fixed- and random-effects models were used to compare outcomes after 24 or 28 weeks of treatment (insulinglargine, n = 1,441; NPH insulin, n = 1,254) according to age (≥65, n = 604 vs < 65, n = 2,091) and age based on treatment (e.g., ≥65 receiving insulin glargine vs NPH insulin). Outcomes included change in HbA1c, fasting blood glucose (FBG), insulin dose, and hypoglycemia incidence and event rates. RESULTS: At end point, participants aged 65 and older receiving insulinglargine had greater reductions in HbA1c and FBG than those receiving similar doses of NPH insulin. In contrast, for participants younger than 65, there were no statistically significant differences in reductions in HbA1c or FBG between insulinglargine and NPH insulin. Daytime hypoglycemia rates were similar in all groups, although the rates of nocturnal symptomatic and severe hypoglycemia were lower with insulin glargine than NPH insulin. CONCLUSION: Addition of insulin glargine to oral antidiabetic drugs in older adults with poor glycemic control may have modestly better glycemic benefits than adding NPH insulin, with low risk of hypoglycemia.
Authors: Derek LeRoith; Geert Jan Biessels; Susan S Braithwaite; Felipe F Casanueva; Boris Draznin; Jeffrey B Halter; Irl B Hirsch; Marie E McDonnell; Mark E Molitch; M Hassan Murad; Alan J Sinclair Journal: J Clin Endocrinol Metab Date: 2019-05-01 Impact factor: 5.958
Authors: Juan José Marín-Peñalver; Iciar Martín-Timón; Cristina Sevillano-Collantes; Francisco Javier Del Cañizo-Gómez Journal: World J Diabetes Date: 2016-09-15
Authors: M Sue Kirkman; Vanessa Jones Briscoe; Nathaniel Clark; Hermes Florez; Linda B Haas; Jeffrey B Halter; Elbert S Huang; Mary T Korytkowski; Medha N Munshi; Peggy Soule Odegard; Richard E Pratley; Carrie S Swift Journal: J Am Geriatr Soc Date: 2012-10-25 Impact factor: 5.562
Authors: M Sue Kirkman; Vanessa Jones Briscoe; Nathaniel Clark; Hermes Florez; Linda B Haas; Jeffrey B Halter; Elbert S Huang; Mary T Korytkowski; Medha N Munshi; Peggy Soule Odegard; Richard E Pratley; Carrie S Swift Journal: Diabetes Care Date: 2012-10-25 Impact factor: 19.112