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Cited by 710

The DOI matches its Crossref record; 36 of the 36 references it cites were found in a registry or an index.

Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 Diabetes

Open access
Holman, Rury R., Thorne, Kerensa I., Farmer, Andrew J., Davies, Melanie J., Keenan, Joanne F., Paul, Sanjoy, Levy, Jonathan C.·2007·New England Journal of Medicine

Abstract

BACKGROUND: Adding insulin to oral therapy in type 2 diabetes mellitus is customary when glycemic control is suboptimal, though evidence supporting specific insulin regimens is limited. METHODS: In an open-label, controlled, multicenter trial, we randomly assigned 708 patients with a suboptimal glycated hemoglobin level (7.0 to 10.0%) who were receiving maximally tolerated doses of metformin and sulfonylurea to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). Outcome measures at 1 year were the mean glycated hemoglobin level, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain. RESULTS: At 1 year, mean glycated hemoglobin levels were similar in the biphasic group (7.3%) and the prandial group (7.2%) (P=0.08) but higher in the basal group (7.6%, P<0.001 for both comparisons). The respective proportions of patients with a glycated hemoglobin level of 6.5% or less were 17.0%, 23.9%, and 8.1%; respective mean numbers of hypoglycemic events per patient per year were 5.7, 12.0, and 2.3; and respective mean weight gains were 4.7 kg, 5.7 kg, and 1.9 kg. Rates of adverse events were similar among the three groups. CONCLUSIONS: A single analogue-insulin formulation added to metformin and sulfonylurea resulted in a glycated hemoglobin level of 6.5% or less in a minority of patients at 1 year. The addition of biphasic or prandial insulin aspart reduced levels more than the addition of basal insulin detemir but was associated with greater risks of hypoglycemia and weight gain. (Current Controlled Trials number, ISRCTN51125379 [controlled-trials.com].).

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Metadata

Authors
Holman, R. R., Thorne, K. I., Farmer, A. J., Davies, M. J., Keenan, J. F., Paul, S., & Levy, J. C.
Venue
New England Journal of Medicine
Published
2007-10-25
Volume
357
Issue
17
Pages
1716-1730
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2096539888
Cited by
710
References
36
FWCI
49.53
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 Diabetes. https://app.cochat.ai/papers/10.1056/nejmoa075392
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Holman, R. R., Thorne, K. I., Farmer, A. J., Davies, M. J., Keenan, J. F., Paul, S., & Levy, J. C. (2007). Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 Diabetes. New England Journal of Medicine. https://doi.org/10.1056/nejmoa075392

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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