Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes.
Open accessAbstract
OBJECTIVE: HOE 901 (Hoechst Marion Roussel, Frankfurt, Germany) is a biosynthetic insulin with a prolonged action. The aim of this study was to compare the effect of the long-acting insulin analog HOE 901 with NPH insulin regarding glycemic control in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 333 type 1 diabetic patients were enrolled in this multinational parallel group trial. Subjects were randomized either to two different formulations of HOE 901 (the formulations differed only in zinc content) or to NPH insulin. The study was only partially blinded because patients can distinguish HOE 901 (a clear solution) from NPH (a cloudy suspension). In addition to premeal injections of regular insulin, patients received HOE 901 at bedtime or NPH once daily at bedtime or twice daily in the morning and at bedtime. RESULTS: Fasting plasma glucose levels were significantly lower with HOE 901 (-1.88 mmol/l. P = 0.0005) as were fasting self-monitored blood glucose levels (-0.80 mmol/l, P = 0.0020). HbA1c levels also showed a significant reduction with HOE 901 (-0.14%) versus NPH (P = 0.030). The overall frequency of hypoglycemia did not differ, but the frequency of nocturnal hypoglycemia was significantly (P = 0.0037) lower with HOE 901 (36 vs. 55%). However, this effect on nocturnal hypoglycemia was significant only versus NPH once daily not NPH twice daily. The pattern of adverse events and injection site reactions with HOE 901 was similar to that with NPH. CONCLUSIONS: This study indicates that HOE 901 achieves better control of fasting glucose and HbA1c levels over 4 weeks, and HOE 901 has a possible safety benefit in terms of nocturnal hypoglycemia.
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The first long-acting once-daily basal insulin, glargine, was approved in 2000; it was designed to have an extended duration of action through amino acid modifications in both chains.
“The first long-acting once-daily basal insulin, glargine, was approved in 2000 (ref. 117). It was designed to have an extended duration of action through amino acid modifications in both chains (A chain A21 asparagine substituted by glycine and B chain elongated by adding two arginines).”
From 100 years of insulin: celebrating the past, present and future of diabetes therapy (2021) · cites this paper as [117]
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- Authors
- Pieber, T. R., Eugène-Jolchine, I., & Derobert, E.
- Affiliations
- University of Graz (AT)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2000-02-01
- Volume
- 23
- Issue
- 2
- Pages
- 157-162
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W1989775174
- Cited by
- 224
- References
- 0
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 6 · 2020: 3 · 2019: 1 · 2018: 5 · 2017: 5 · 2016: 1 · 2015: 6 · 2014: 5 · 2013: 4 · 2012: 3
- FWCI
- 16.71
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion)
- Research Publications (Maastricht University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- long-acting insulin analogues, NPH insulin, type 1 diabetes, glycemic control, HbA1c, fasting blood glucose, nocturnal hypoglycemia, hypoglycemia, zinc content, insulin formulations, adverse events, injection site reactions
- MeSH terms
- Insulin Glargine, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Insulin, Insulin, Isophane, Male, Middle Aged, Safety, Single-Blind Method, Fructosamine, Insulin, Long-Acting
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