GUIDE study: double‐blind comparison of once‐daily gliclazide MR and glimepiride in type 2 diabetic patients
Open accessAbstract
Background Progressive β‐cell failure is a characteristic feature of type 2 diabetes; consequently, β‐cell secretagogues are useful for achieving sufficient glycaemic control. The European GUIDE study is the first large‐scale head‐to‐head comparison of two sulphonylureas designed for once‐daily administration used under conditions of everyday clinical practice. Design Eight hundred and forty‐five type 2 diabetic patients were randomized to either gliclazide modified release (MR) 30–120 mg daily or glimepiride 1–6 mg daily as monotherapy or in combination with their current treatment (metformin or an α‐glucosidase inhibitor) according to a double‐blind, 27‐week, parallel‐group design. Efficacy was evaluated by HbA1c and safety by hypoglycaemic episodes using the European Agency definition. Results HbA 1c decreased similarly in both groups from 8·4% to 7·2% on gliclazide MR and from 8·2% to 7·2% on glimepiride. Approximately 50% of the patients achieved HbA1c levels less than 7%, and 25% less than 6·5%. The mean difference between groups of the final HbA 1c was −0·06% (noninferiority test P < 0·0001). No hypoglycaemia requiring external assistance occurred. Hypoglycaemia with blood glucose level < 3 mmol L −1 occurred significantly less frequently ( P = 0·003) with gliclazide MR (3·7% of patients) compared with glimepiride (8·9% of patients). The distribution of the sulphonylurea doses was similar in both groups. Conclusions This study provides new insights into therapeutic strategies using sulphonylureas. It shows that gliclazide MR is at least as effective as glimepiride, either as monotherapy or in combination. The safety of gliclazide MR was significantly better, demonstrating approximately 50% fewer confirmed hypoglycaemic episodes in comparison with glimepiride.
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In a multicenter, double-blind, controlled trial in Europe comparing modified release gliclazide with glimepiride over 6 months, both groups achieved a reduction of A1C of around 1.0%, with fewer patients reporting hypoglycemia with modified release gliclazide (3.7%) compared with glimepiride (8.9%), and severe hypoglycemia did not occur.
“Both groups achieved a reduction of A1C of around 1.0%, with fewer patients reporting hypoglycemia with modified release gliclazide (3.7%) compared with glimepiride (8.9%).Severe hypoglycemia did not occur.”
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- Authors
- Schernthaner, G., Grimaldi, A., Di Mario, U., Drzewoski, J., Kempler, P., Kvapil, M., Novials, A., Rottiers, R., Rutten, G. E. H. M., & Shaw, K. M.
- Affiliations
- Krankenanstalt Rudolfstiftung der Stadt Wien (AT)
- Pitié-Salpêtrière Hospital (FR)
- Medical University of Lodz (PL)
- Semmelweis University (HU)
- Ghent University Hospital (BE)
- Utrecht University (NL)
- Queen Alexandra Hospital (GB)
- Corresponding author
- Schernthaner, G.
- Venue
- European Journal of Clinical Investigation
- Publisher
- Wiley
- Published
- 2004-08
- Volume
- 34
- Issue
- 8
- Pages
- 535-542
- ISSN
- 0014-2972 (ISSN-L)
- 1365-2362
- OpenAlex
- W2172035122
- Cited by
- 271
- References
- 29
- Citations by year
- 2026: 6 · 2025: 8 · 2024: 8 · 2023: 10 · 2022: 9 · 2021: 14 · 2020: 21 · 2019: 9 · 2018: 12 · 2017: 11 · 2016: 14 · 2015: 17 · 2014: 15 · 2013: 17 · 2012: 20
- FWCI
- 6.99
- Type
- journal article
- Language
- en
- Open access
- green
- dspace.library.uu.nl
- Licence
- Locations
- European Journal of Clinical Investigation (publishedVersion)
- PubMed (publishedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- 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
- gliclazide modified release, glimepiride, type 2 diabetes, sulfonylureas, once-daily dosing, HbA1c, glycemic control, hypoglycemia, non-inferiority, metformin combination therapy, alpha-glucosidase inhibitors
- MeSH terms
- Diabetes Mellitus, Type 2, Double-Blind Method, Female, Gliclazide, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Male, Middle Aged, Sulfonylurea Compounds, Treatment Outcome
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