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Cited by 433Diabetes Treatment and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

Comparison of Bedtime Insulin Regimens in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Yki-Järvinen, Hannele, Ryysy, Leena, Nikkilä, Kati, Tulokas, Timo, Vanamo, Raimo, Heikkilä, Marjatta·1999·Annals of Internal Medicine
DOI 10.7326/0003-4819-130-5-199903020-00002
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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.

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Authors
Yki-Järvinen, H., Ryysy, L., Nikkilä, K., Tulokas, T., Vanamo, R., & Heikkilä, M.
Affiliations
  • From University of Helsinki, Helsinki; Kymenlaakso Central Hospital, Kotka; Jorvi Hospital and Orion, Espoo; Lapland Central Hospital, Rovaniemi; and South Carelian Central Hospital, Lappeenranta, Finland.
  • University of Helsinki (FI)
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
1999-03-02
Volume
130
Issue
5
Pages
389-396
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/0003-4819-130-5-199903020-00002
OpenAlex
W1981978041
Cited by
433
References
21
Citations by year
2026: 1 · 2025: 3 · 2024: 6 · 2023: 5 · 2022: 10 · 2021: 3 · 2020: 5 · 2019: 4 · 2018: 7 · 2017: 4 · 2016: 12 · 2015: 9 · 2014: 9 · 2013: 8 · 2012: 17
FWCI
17.74
Type
journal article
Language
en
Open access
closed
Licence
www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
type 2 diabetes, bedtime insulin, intermediate-acting insulin, metformin, glibenclamide, sulfonylurea therapy, weight gain, glycemic control, HbA1c, hypoglycemia, combination therapy, insulin dose adjustment, oral antidiabetic drugs, uncontrolled diabetes
MeSH terms
Albuminuria, Blood Glucose, Blood Pressure, C-Peptide, Diabetes Mellitus, Type 2, Drug Administration Schedule, Drug Therapy, Combination, Follow-Up Studies, Glyburide, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Lipids, Metformin, Middle Aged, Weight Gain

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