Stanley H Hsia1. 1. Division of Endocrinology, Charles R. Drew University of Medicine and Science, Los Angeles, CA 90059, USA. stanleyhsia@cdrewu.edu
Abstract
AIMS: We compared basal regimens of glargine or NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients who were sub-optimally controlled on maximally tolerated doses of combination oral agents. METHODS:Eighty-five subjects were randomized to 26 weeks of open-label, add-on therapy using single doses of bedtime NPH, bedtime glargine, or morning glargine; initially through an 8-week dose titration phase, followed by a 16-week maintenance phase during which insulin doses were adjusted only to avoid symptomatic hypoglycemia. RESULTS: All three groups were comparable at baseline (mean HbA(1c) 9.3 ± 1.4%), and improved their HbA(1c) (to 7.8 ± 1.3%), fasting, and pre-supper glucose readings, with no significant between-group differences. Weight gain was greater with either glargine regimen (+3.1 ± 4.1 kg and +1.7 ± 4.2 kg) compared to NPH (-0.2 ± 3.9 kg), despite comparable total insulin doses. Pre-supper hypoglycemia occurred more frequently with morning glargine, but nocturnal hypoglycemia and improvements in treatment satisfaction did not differ among groups. CONCLUSIONS: Among inner city ethnic minority type 2 diabetic patients in the U.S., we found no differences in basal glycemic control or nocturnal hypoglycemia between glargine and NPH, although glargine precipitated greater weight gain.
RCT Entities:
AIMS: We compared basal regimens of glargine or NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabeticpatients who were sub-optimally controlled on maximally tolerated doses of combination oral agents. METHODS: Eighty-five subjects were randomized to 26 weeks of open-label, add-on therapy using single doses of bedtime NPH, bedtime glargine, or morning glargine; initially through an 8-week dose titration phase, followed by a 16-week maintenance phase during which insulin doses were adjusted only to avoid symptomatic hypoglycemia. RESULTS: All three groups were comparable at baseline (mean HbA(1c) 9.3 ± 1.4%), and improved their HbA(1c) (to 7.8 ± 1.3%), fasting, and pre-supper glucose readings, with no significant between-group differences. Weight gain was greater with either glargine regimen (+3.1 ± 4.1 kg and +1.7 ± 4.2 kg) compared to NPH (-0.2 ± 3.9 kg), despite comparable total insulin doses. Pre-supper hypoglycemia occurred more frequently with morning glargine, but nocturnal hypoglycemia and improvements in treatment satisfaction did not differ among groups. CONCLUSIONS: Among inner city ethnic minority type 2 diabeticpatients in the U.S., we found no differences in basal glycemic control or nocturnal hypoglycemia between glargine and NPH, although glargine precipitated greater weight gain.
Authors: Lauren J Lee; Andrew P Yu; Scott J Johnson; Howard G Birnbaum; Pavel Atanasov; Don P Buesching; Jeffrey A Jackson; Jaime A Davidson Journal: Diabetes Res Clin Pract Date: 2009-11-05 Impact factor: 5.602
Authors: Thomas Semlitsch; Jennifer Engler; Andrea Siebenhofer; Klaus Jeitler; Andrea Berghold; Karl Horvath Journal: Cochrane Database Syst Rev Date: 2020-11-09
Authors: Przemyslaw Rys; Piotr Wojciechowski; Agnieszka Rogoz-Sitek; Grzegorz Niesyczyński; Joanna Lis; Albert Syta; Maciej T Malecki Journal: Acta Diabetol Date: 2015-01-14 Impact factor: 4.280
Authors: Bipin Sethi; A G Unnikrishnan; Vageesh Ayyar; P K Jabbar; K K Ganguly; Sudhir Bhandari; Ashu Rastogi; Rajarshi Mukherjee; Vivek Sundaram; Adlyne R Asirvatham Journal: Diabetes Ther Date: 2022-06-30 Impact factor: 3.595