Trial intelligence / Profile preview

HMH Trial: Basal-Bolus vs Sliding Scale Insulin in Hospitalized Patients

NCT01136746Phase 3

Key facts

Status
Terminated
Start
Mar 2011
Primary completion
Nov 2011
Countries
1
Modality
Recombinant Proteins and Enzymes
Conditions
hyperglycemia
01

Overview

Phase 3, randomised, open-label trial of insulin glargine and insulin lispro in hyperglycemia (2 arms), sponsored by Eli Lilly and Company. Primary endpoints: Mean Plasma Glucose and Percentage of Capillary Plasma Glucose Measurements Within Range. Started Mar 2011; status: terminated.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Sliding Scale

    Human regular insulin 4 times daily as needed

  • Basal-Bolus

    Insulin glargine once daily + Insulin lispro 3-4 times daily

03

Who it enrols

Adult non-critically ill inpatients with hyperglycemia (140-400 mg/dL) and no known history of diabetes.

04

Endpoints

Primary

  • Mean Plasma Glucose

  • Percentage of Capillary Plasma Glucose Measurements Within Range

Secondary

  • Incidence of Hypoglycemia and Severe Hypoglycemia Episodes

  • Length of Hospital Stay Post-randomization

  • Total Daily Dose of Insulin

  • Treatment-emergent Adverse Events

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