drugset / Trial / NCT01081938

Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition

NCT01081938

Phase 4 Terminated 15 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: 1- Proportion of patients with mean daily glycemia \<140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale. Secondary Objective: 1. Incidence of moderate hyperglycemia (\>140mg/dL) during the treatment period. 2. Incidence of hypoglycemia (\<60mg/dL and \< 40mg/dL) during the treatment period. 3. Incidence of severe hyperglycemia (\>400mg/dL) during the treatment period. 4. Total dose of insulin and correction dose in each group.

Timeline

Start
2010-02
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous
Subject insulin glargine Protein / enzyme biologic Subcutaneous