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Randomized double-blind placebo-controlled trial to evaluate the effect of the ACTH4–9 analogue ORG 2766 in IDDM patients with neuropathy

Diabetologia volume 37, pages 408–413 (1994)Cite this article

Summary

In this study we report a randomized double-blind, placebo-controlled trial to evaluate the effect of ORG 2766 in IDDM patients with peripheral neuropathy. Sixty-two patients were selected based on the following criteria: abnormal vibration perception threshold above the 95th-percentile adjusted for age and/or abnormal warm temperature threshold, both measured in the right hand. The patients were randomized into two treatment groups after baseline studies: Group 1 was treated with placebo and Group 2 was treated with 3 mg of the ACTH4–9 analogue ORG 2766 every 24 h. The total study period was 1 year. After 1 year of treatment there was a significant improvement in vibration threshold in Group 1 compared to Group 2. No other parameters improved in the study period. The number of patients selected may have been too small to detect a more important treatment effect. We conclude from this study that ORG 2766 can improve vibration threshold, indicating large myelinated fibre function, but does not affect any the other neurophysiological function tests.

Abbreviations

IDDM:

Insulin-dependent diabetes mellitus

NIDDM:

non-insulin-dependent diabetes mellitus

ACTH:

adrenocorticotropic hormone

SNCV:

sensory nerve conduction velocity

MNCV:

motor nerve conduction velocity

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Author information

Affiliations

  1. Department of Internal Medicine, University of Utrecht, The Netherlands

    B. Bravenboer & D. W. Erkelens

  2. Department of Clinical Neurophysiology, University of Utrecht, The Netherlands

    P. H. Hendrikse, P. L. Oey, A. C. van Huffelen & C. Groenhout

  3. Department of Medical Pharmacology, University of Utrecht, The Netherlands

    W. H. Gispen

Authors
  1. B. Bravenboer
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  2. P. H. Hendrikse
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  3. P. L. Oey
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  4. A. C. van Huffelen
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  5. C. Groenhout
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  6. W. H. Gispen
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  7. D. W. Erkelens
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Bravenboer, B., Hendrikse, P.H., Oey, P.L. et al. Randomized double-blind placebo-controlled trial to evaluate the effect of the ACTH4–9 analogue ORG 2766 in IDDM patients with neuropathy. Diabetologia 37, 408–413 (1994). https://doi.org/10.1007/BF00408479

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  • DOI: https://doi.org/10.1007/BF00408479

Key words

  • ACTH4–9 analogue
  • diabetic neuropathy