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A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes

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Rosenstock, J., Davies, M., Home, P. D., Larsen, J., Koenen, C., Schernthaner, G.·2008·Diabetologia
DOI 10.1007/s00125-007-0911-xPMC PMC2235909
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Abstract

AIMS/HYPOTHESIS: This 52-week multinational, randomised, open-label, parallel-group, non-inferiority trial compared clinical outcomes following supplementation of oral glucose-lowering drugs with basal insulin analogues detemir and glargine in type 2 diabetic patients. METHODS: Insulin-naive adults (n=582, HbA(1c) 7.5-10.0%, BMI <or= 40.0 kg/m(2)) were randomised 1:1 to receive insulin detemir or glargine once daily (evening) actively titrated to target fasting plasma glucose (FPG) <or= 6.0 mmol/l. An additional morning insulin detemir dose was permitted if pre-dinner plasma glucose (PG) was >7.0 mmol/l after achieving FPG <7.0 mmol/l. Due to labelling restrictions, no second glargine dose was allowed. RESULTS: Baseline HbA(1c) decreased from 8.6 to 7.2 and 7.1% (NS) with detemir and glargine, respectively. FPG improved from 10.8 to 7.1 and 7.0 mmol/l (NS), respectively. With detemir, 45% of participants completed the study on once daily dosing and 55% on twice daily dosing, with no difference in HbA(1c). Overall, 52% of participants achieved HbA(1c) <or= 7.0%: 33% (detemir) and 35% (glargine) without hypoglycaemia. Within-participant variability for self-monitored FPG and pre-dinner PG did not differ by insulin treatment, nor did the relative risk of overall or nocturnal hypoglycaemia. Modest reductions in weight gain were seen with detemir vs glargine in completers (3.0 vs 3.9 kg, p=0.01) and in the intention-to-treat population (2.7 vs 3.5 kg, p=0.03), primarily related to completers on once-daily detemir. Mean daily detemir dose was higher (0.78 U/kg [0.52 with once daily dosing, 1.00 U/kg with twice daily dosing]) than glargine (0.44 IU/kg). Injection site reactions were more frequent with detemir (4.5 vs 1.4%). CONCLUSIONS/INTERPRETATION: Supplementation of oral agents with detemir or glargine achieves clinically important improvements in glycaemic control with low risk of hypoglycaemia. Non-inferiority was demonstrated for detemir using higher insulin doses (mainly patients on twice daily dosing); weight gain was somewhat reduced with once daily insulin detemir.

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  • Intensive glycemic control reduced retinopathy progression in ACCORD (7.3% vs 10.4%; P = .003) and incidence of nephropathy in ADVANCE (4.1% vs 5.2%; P = .006).

    “Intensive control reduced retinopathy progression in ACCORD (7.3% vs 10.4%; P = .003)42 and incidence of nephropathy in ADVANCE (4.1% vs 5.2%; P = .006).40”

    From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [42]

    Citation 42 is attached to the ACCORD retinopathy result; the ADVANCE result has a separate citation. Searches of our copy for ACCORD, retinopathy progression, and the reported percentages found no supporting passage. The Methods and Results instead describe a 52-week comparison of insulin detemir and glargine, with glycaemic control and hypoglycaemia outcomes; no page numbers were available. (LLM, conf=0.78)

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Research works printed but not linked: 21

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Authors
Rosenstock, J., Davies, M., Home, P. D., Larsen, J., Koenen, C., & Schernthaner, G.
Affiliations
  • University of Leicester (GB)
  • Newcastle University (GB)
  • Novo Nordisk (Denmark) (DK)
  • Krankenanstalt Rudolfstiftung der Stadt Wien (AT)
Corresponding author
Rosenstock, J.
ORCID
Venue
Diabetologia
Publisher
Springer Science and Business Media LLC
Published
2008-01-16
Volume
51
Issue
3
Pages
408-416
ISSN
  • 0012-186X (ISSN-L)
  • 1432-0428
DOI
10.1007/s00125-007-0911-x
PMC
PMC2235909
OpenAlex
W2127521907
Cited by
447
References
0
Citations by year
2026: 2 · 2025: 4 · 2024: 5 · 2023: 11 · 2022: 8 · 2021: 14 · 2020: 9 · 2019: 18 · 2018: 20 · 2017: 24 · 2016: 20 · 2015: 31 · 2014: 40 · 2013: 42 · 2012: 34
FWCI
39.67
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetologia (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Newcastle University ePrints (Newcastle Univesity)
Funders
  • American Diabetes Association
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca
  • GlaxoSmithKline
  • Sanofi
  • MannKind Corporation
  • Novo Nordisk
  • Servier
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
insulin detemir, insulin glargine, basal insulin analogues, type 2 diabetes, insulin-naive patients, antidiabetic drugs, treat-to-target, HbA1c, fasting blood glucose, hypoglycemia, weight gain, insulin dose, insulin dose adjustment, non-inferiority, obesity, self-monitoring of blood glucose
MeSH terms
Insulin Glargine, Insulin Detemir, Aged, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Blood Glucose Self-Monitoring, Body Mass Index, Insulin, Long-Acting

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