Ultra-rapid BioChaperone Lispro improves postprandial blood glucose excursions vs insulin lispro in a 14-day crossover treatment study in people with type 1 diabetes

Diabetes Obes Metab. 2018 Nov;20(11):2627-2632. doi: 10.1111/dom.13442. Epub 2018 Jul 12.

Abstract

Aim: To investigate the safety and efficacy of BioChaperone Lispo (BCLIS), an ultra-rapid formulation of insulin lispro (LIS) in people with type 1 diabetes.

Materials and methods: In this randomized, double-blind study, participants self-administered individualized bolus doses of BCLIS or LIS during two 14-day periods in a crossover fashion. Postprandial blood glucose (BG) was assessed after individualized solid mixed meal tests (MMTs) (50% carbohydrate, 29% fat, 21% protein), with additional randomization for the sequence of timing of insulin administration, immediately (t0), 15 minutes before (t - 15) and 15 minutes after (t + 15) meal start on days 1, 2 and 3, and with t0 administration on day 14. Pharmacokinetic (PK) variables were assessed for t0 MMTs. Participants also used individualized BCLIS or LIS doses immediately before meals during two 10-day outpatient periods with an unchanged basal insulin regimen.

Results: Overall, 35 participants completed both treatment periods. In MMTs with t0 administration, the higher early postprandial PK exposure of BCLIS led to significant reductions in 1- to 2-hour postprandial BG excursions by 30% to 40% vs LIS and the accelerated absorption and action of BCLIS persisted over 14 days. There was no difference in glucose excursion over the full 360-minute postprandial period. Postprandial BG control was similar between BCLIS injected at t + 15 and LIS injected at t0. BCLIS was shown to have safety and tolerability similar to LIS. No injection site reactions occurred with BCLIS.

Conclusions: BCLIS was well tolerated and safe over 14 days of treatment and significantly improved postprandial BG vs LIS when administered at mealtime.

Keywords: antidiabetic drug; insulin analogues; insulin therapy; pharmacokinetics; phase I-II study; type 1 diabetes.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Blood Glucose / drug effects*
  • Blood Glucose / metabolism
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / complications
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 1 / metabolism*
  • Double-Blind Method
  • Female
  • Humans
  • Hypoglycemic Agents / pharmacokinetics
  • Hypoglycemic Agents / therapeutic use
  • Insulin Lispro / pharmacokinetics*
  • Insulin Lispro / therapeutic use*
  • Male
  • Meals
  • Middle Aged
  • Postprandial Period / drug effects
  • Young Adult

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin Lispro