Field efficacy and safety of protamine zinc recombinant human insulin in 276 dogs with diabetes mellitus

Domest Anim Endocrinol. 2021 Apr:75:106575. doi: 10.1016/j.domaniend.2020.106575. Epub 2020 Oct 14.

Abstract

Twice-daily (BID) insulin injections are a major deterrence to owners treating dogs with diabetes mellitus (DM). The hypothesis for this study was that Protamine Zinc Recombinant Human Insulin (PZIR) is safe and efficacious as a once-daily (SID) treatment for canine DM. This was a prospective, baseline-controlled, multi-center study over 182 ± 5 d. Two hundred seventy-six client-owned dogs with naturally occurring DM (naïve or pre-treated with insulin) were enrolled in the study. Enrollment was based upon demonstration of hyperglycemia, glycosuria, and ≥1 diabetic clinical sign (polyuria (PU), polydipsia (PD), or weight loss). Insulin treatment was initiated at 0.5-1.0 IU/kg SID. An improvement in at least one lab parameter related to DM (mean BG, min BG, Fructosamine) and one clinical parameter (PU/PD, body weight) was achieved in 72% of dogs (80% of naive, 62% of pre-treated). Dogs treated SID and BID showed improvement in 71% and 74% of cases, respectively. In naïve dogs, mean and minimum BG and fructosamine were significantly decreased (P < 0.05) by d 7 and 21, respectively, and in pre-treated dogs by d 63. By d 84, PU/PD improved in 90% and 88% of dogs, respectively, and the mean successful insulin dose was 1.4 IU/kg/d. Safety parameters were measured in 276 dogs for up to 182 d; clinical hypoglycemia occurred in 8.9% of dogs. We conclude that PZIR safely and effectively improved glycemic parameters and clinical signs in naïve and pre-treated diabetic dogs. The significant percentage of dogs on SID treatment with improvement in hyperglycemia and clinical signs confirms the prolonged action of PZIR in many dogs.

Keywords: Fructosamine; Glucose curve; Hyperglycemia; Posology; ProZinc; Quality of life.

Publication types

  • Multicenter Study

MeSH terms

  • Animals
  • Blood Glucose
  • Diabetes Mellitus* / drug therapy
  • Diabetes Mellitus* / veterinary
  • Dog Diseases* / drug therapy
  • Dogs
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Insulin / therapeutic use
  • Prospective Studies
  • Protamines

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin
  • Protamines
  • protamine zinc