Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial - PubMed (original) (raw)
Clinical Trial
Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial
H Yki-Järvinen et al. Ann Intern Med. 1999.
Abstract
Background: Compared with other insulin regimens, combination therapy with oral hypoglycemic agents and bedtime insulin produces similar improvement in glycemic control but induces less weight gain.
Objective: To determine whether bedtime insulin regimens differ with respect to their effects on weight gain in patients with type 2 diabetes.
Design: Randomized, controlled trial.
Setting: Four outpatient clinics at central hospitals.
Patients: 96 patients (mean age, 58 +/- 1 years; mean body mass index, 29 +/- 1 kg/m2) whose type 2 diabetes was poorly controlled with sulfonylurea therapy (mean glycosylated hemoglobin value, 9.9% +/- 0.2%; mean fasting plasma glucose level, 11.9 +/- 0.3 mmol/L [214 +/- 5 mg/dL]).
Intervention: Random assignment to 1 year of treatment with bedtime intermediate-acting insulin plus glyburide (10.5 mg) and placebo, metformin (2 g) and placebo, glyburide and metformin, or a second injection of intermediate-acting insulin in the morning. Patients were taught to adjust the bedtime insulin dose on the basis of fasting glucose measurements.
Measurements: Body weight, biochemical and symptomatic hypoglycemias, and indices of glycemic control.
Results: At 1 year, body weight remained unchanged in patients receiving bedtime insulin plus metformin (mean change, 0.9 +/- 1.2 kg; P < 0.001 compared with all other groups) but increased by 3.9 +/- 0.7 kg, 3.6 +/- 1.2 kg, and 4.6 +/- 1.0 kg in patients receiving bedtime insulin plus glyburide, those receiving bedtime insulin plus both oral drugs, and those receiving bedtime and morning insulin, respectively. The greatest decrease in the glycosylated hemoglobin value was observed in the bedtime insulin and metformin group (from 9.7% +/- 0.4% to 7.2% +/- 0.2% [difference, -2.5 +/- 0.4 percentage points] at 1 year; P < 0.001 compared with 0 months and P < 0.05 compared with other groups). This group also had significantly fewer symptomatic and biochemical cases of hypoglycemia (P < 0.05) than the other groups.
Conclusions: Combination therapy with bedtime insulin plus metformin prevents weight gain. This regimen also seems superior to other bedtime insulin regimens with respect to improvement in glycemic control and frequency of hypoglycemia.
Comment in
- Treating type 2 diabetes with respect.
Nathan DM. Nathan DM. Ann Intern Med. 1999 Mar 2;130(5):440-1. doi: 10.7326/0003-4819-130-5-199903020-00016. Ann Intern Med. 1999. PMID: 10068419 No abstract available.
Similar articles
- Addition of neutral protamine lispro insulin or insulin glargine to oral type 2 diabetes regimens for patients with suboptimal glycemic control: a randomized trial.
Esposito K, Ciotola M, Maiorino MI, Gualdiero R, Schisano B, Ceriello A, Beneduce F, Feola G, Giugliano D. Esposito K, et al. Ann Intern Med. 2008 Oct 21;149(8):531-9. doi: 10.7326/0003-4819-149-8-200810210-00005. Ann Intern Med. 2008. PMID: 18936501 Clinical Trial. - Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients.
Chow CC, Tsang LW, Sorensen JP, Cockram CS. Chow CC, et al. Diabetes Care. 1995 Mar;18(3):307-14. doi: 10.2337/diacare.18.3.307. Diabetes Care. 1995. PMID: 7555472 Clinical Trial. - Mealtime 50/50 basal + prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and postprandial blood glucose levels in patients with type 2 diabetes: a multinational, 24-week, randomized, open-label, parallel-group comparison.
Robbins DC, Beisswenger PJ, Ceriello A, Goldberg RB, Moses RG, Pagkalos EM, Milicevic Z, Jones CA, Sarwat S, Tan MH. Robbins DC, et al. Clin Ther. 2007 Nov;29(11):2349-64. doi: 10.1016/j.clinthera.2007.11.016. Clin Ther. 2007. PMID: 18158076 Clinical Trial. - Repaglinide : a pharmacoeconomic review of its use in type 2 diabetes mellitus.
Plosker GL, Figgitt DP. Plosker GL, et al. Pharmacoeconomics. 2004;22(6):389-411. doi: 10.2165/00019053-200422060-00005. Pharmacoeconomics. 2004. PMID: 15099124 Review. - Glyburide/metformin HCl clinical overview.
Seymour A. Seymour A. Manag Care. 2001 Feb;10(2 Suppl):11-6. Manag Care. 2001. PMID: 11729403 Review. No abstract available.
Cited by
- Japanese Clinical Practice Guideline for Diabetes 2019.
Araki E, Goto A, Kondo T, Noda M, Noto H, Origasa H, Osawa H, Taguchi A, Tanizawa Y, Tobe K, Yoshioka N. Araki E, et al. J Diabetes Investig. 2020 Jul;11(4):1020-1076. doi: 10.1111/jdi.13306. J Diabetes Investig. 2020. PMID: 33021749 Free PMC article. No abstract available. - Insulin therapy for type 2 diabetes.
Sasali A, Leahy JL. Sasali A, et al. Curr Diab Rep. 2003 Oct;3(5):378-85. doi: 10.1007/s11892-003-0081-2. Curr Diab Rep. 2003. PMID: 12975027 Review. - Hypoglycaemia in Type 2 diabetes.
Amiel SA, Dixon T, Mann R, Jameson K. Amiel SA, et al. Diabet Med. 2008 Mar;25(3):245-54. doi: 10.1111/j.1464-5491.2007.02341.x. Epub 2008 Jan 21. Diabet Med. 2008. PMID: 18215172 Free PMC article. Review. - Comparative evaluation of incretin-based antidiabetic medications and alternative therapies to be added to metformin in the case of monotherapy failure.
Nauck MA, Vardarli I. Nauck MA, et al. J Diabetes Investig. 2010 Apr 22;1(1-2):24-36. doi: 10.1111/j.2040-1124.2010.00004.x. J Diabetes Investig. 2010. PMID: 24843405 Free PMC article. Review. - Addition of basal insulin to oral antidiabetic agents: a goal-directed approach to type 2 diabetes therapy.
Kuritzky L. Kuritzky L. MedGenMed. 2006 Nov 15;8(4):34. MedGenMed. 2006. PMID: 17415316 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical