Determir

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Hermansen et al, 200119859 adult patients with type 1 diabetes. (56 patients completed the trial)
Aged 19–52 years
7 sites in Denmark
2-week run-in period followed by randomisation in blocks of four to two 6-week treatment periods
  1. insulin detemir (100 units/ml)
  2. isophane insulin
Treatments were injected subcutaneously between 21:00 and 23:00 and human short-acting insulin was given 30 min before each main meal
8-point self-monitored blood glucose profile
24-hour serum glucose profile.
Serum fasting blood glucose
Hypoglycaemia (classified as minor if self dealt with or major if required help from a third party or intravenous glucose or glucagon treatment was required)
Adverse events
The maximum glucose concentrations were not statistically different between the two treatment groups. The mean serum glucose was different between the two treatment groups; during the night serum glucose was higher with detemir than with isophane insulin.
There was no significant difference between the treatment groups in the area under the curve of the 24-hour serum glucose profile. No significant difference was seen between the two treatment groups in the 8-point self- monitored blood glucose profile for the last week of the treatment period
There was no significant difference in the mean fructosamine level between the two treatment groups
There were significantly smaller numbers of hypoglycaemia events in the last week of detemir treatment compared with isophane insulin treatment: detemir 74 (60%) vs. isophane insulin 116 (77%), p < 0.05
There were similar adverse events between the two treatment groups
No description of how randomisation took place
Supported by Novo Nordisk
RCT crossoverIb
Vague et al, 2003197448 patients with type 1 diabetes. (425 completed trial, n ≤ 419 analysed)
Aged 38.9 ± 13.3 years for detemir group and 41.8 ± 14.2 years for intermediate-acting (isophane) insulin group
Europe
Detemir (1200 nmol/ml) before breakfast and bedtime (n = 284)
versus
intermediate-acting insulin (isophane) (600 nmol/ml) before breakfast and bedtime (n = 141)
Trial length: 6 months (first month considered as a titration phase)
Randomised via a 2:1 ratio
  1. Mean HbA1c (n = 419)
  2. Mean fasting plasma glucose (n = 412)
  3. Major hypoglycaemic events
  4. Minor hypoglycaemic events
  5. Body weight
  1. 7.60 ± 0.09% vs. 7.64 ± 0.10%, p = 0.61
  2. 9.19 ± 0.44 vs. 9.94 ± 0.52 mmol/l, p = 0.09
  3. RR 0.65, 95% CI 0.28 to 1.50, p = 0.312
  4. RR 0.72, 95% CI 0.56 to 0.93, p = 0.011
  5. 70.9 ± 0.28 vs. 71.8 ± 0.33 kg, p = 0.001
Withdrew from study due to:
detemir group: ineffective therapy (n = 1), non- compliance (n = 1), ‘other reasons’ (n = 1), adverse events (n = 2)
intermediate-acting insulin: ineffective therapy (n = 2), ‘other reasons’ (n = 3)
multicentre RCTIb

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

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