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Basal Plus vs Sliding Scale Insulin in Nursing Home Residents

NCT01131052Phase 4

Key facts

Status
Completed
Start
Mar 2011
Primary completion
Dec 2013
Countries
1
Modality
Recombinant Proteins and Enzymes
Conditions
type 2 diabetes mellitus (T2DM)
01

Overview

Phase 4, randomised, open-label trial of insulin glargine in type 2 diabetes mellitus (T2DM) (2 arms). Primary endpoints: Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL at 3 months, Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL at 3 months and 1 more. Started Mar 2011; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • BASAL PLUS

    Insulin Glargine once daily + Insulin Glulisine before meals/bedtime as needed

  • SSRI

    Sliding Scale Regular Insulin before meals/bedtime as needed

03

Endpoints

Primary

  • Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL

  • Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL

  • Mean of Weekly Fasting Blood Glucose Concentration

Secondary

  • Mean Blood Glucose Concentration

  • Mean of Glycosylated Hemoglobin (hbA1c)

  • Mean of Daily Blood Glucose Concentration

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