Hypoglycaemia: no difference between human and animal derived insulins

Clinical bottom line (level 4)

  1. In insulin using diabetics, taking human or animal-derived insulins did not alter the likelihood of reporting hypoglycaemia (NNF = 53 for 12 months)
  2. In insulin taking diabetics, about one third experienced symptoms of hypoglycaemia at least weekly
Klein et al: Diabetes Care 1997; 20 (3): 336-339
Expires August 2003

The study

Prospective cohort study with unblinded, unobjective outcomes, adjusted for confounding factors, not validated in an independent set of patients.

Setting: 11 county area in USA

740 patients (aged ?, ?% male) insulin-dependent diabetes mellitus (IDDM) with onset <30y

Excluded if
  • patients taking none, or a mix of insulin derivations at either 4 or 10 year review




    • multivariate linear regression

    100% followed for maximum 10 years
    Outcomes studied:
  • hypoglycaemic events more than once per week combined human/animal insulin users
  • frequency of hypoglycaemic reactions

    • The evidence

    outcome time to outcome number of patients/total number %
    (95% CI)    		 NNF
    (95% CI)
    hypoglycaemic events more than once per week 10 years 271/740 36.6%
    (33.2% to 40.1%)    		 3
    (2 to 3)
    frequency of hypoglycaemic reactions 12 months 360/388 92.8%
    (90.2% to 95.4%)    		 53
    (-48 to 17)

    • There was no difference between the human and animal insulin users.
    • Decreasing body mass index was a prognostic factor for increasing frequency of hypoglycaemic reactions (OR 0.94; 95% CI: 0.91 to 0.97), as was decreasing glycosylated haemoglobin (OR 0.88; 95% CI: 0.81 to 0.96).

    Comments

    1. Episodes of hypoglycaemia based on recollections over the previous year.
    2. The population in the tables n=740, wheras the text details 741 patients. This difference is unlikely to materially affect the results.
    3. This study is largely of historical interest, as the vast majority of insulin-users are on human -derived insulins.

    Citation

    1. Klein BEK, Klein R, Moss SE: Risk of hypoglycaemia in users of human insulin. Diabetes Care 1997; 20 (3): 336-339
    Contributor: Bob Phillips and Clare Wotton, August 1999
    Reviewer: Wai-Lam Chan

    Clinical Question.
    Patient insulin using diabetics
    Intervention or Exposure human insulin
    Comparison animal-derived insulin
    Outcome risk of hypoglycaemia