Clinical Trial: Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Clinical Trial of Subcutaneous Analog Basal Bolus Therapy Versus Sliding Scale Human Regular Insulin in the Hospital Management of Hyperglycemia in Non-Critical

Brief Summary: The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.

Detailed Summary: This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose <140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose <180 mg/dL for patients who are eating [predose plasma glucose <140 mg/dL for patients with nil per os (NPO) orders]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target <140 mg/dL in patients who are eating or have NPO orders.
Sponsor: Eli Lilly and Company

Current Primary Outcome:

  • Mean Plasma Glucose (MPG) Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.
  • Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.


Original Primary Outcome:

  • Mean Plasma Glucose (MPG) Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
  • Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]


Current Secondary Outcome:

  • Mean Plasma Glucose (MPG) by Hospital Day [ Time Frame: Day 1 up to day 7 of hospital study period ]
    The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.
  • Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Mean Fasting Plasma Glucose (FPG) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Mean FPG Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • TDD of Insulin (Units/kg) Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • TDD of Insulin (Units) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • TDD of Insulin (Units/kg) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Length of Hospital Stay Post-randomization Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    Due to low enrollment, this outcome measure was not analyzed.
  • Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    Hypoglycemia was defined as any

    Original Secondary Outcome:

    • MPG by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Plasma Glucose measurements within range 71 to 179 mg/dL by hospital day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Percentage of patients achieving MPG within range 71 to 179 mg/dL and within the target of 100 to 179 mg/dL throughout hospital study period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Percentage of patients achieving MPG within range 71 to 179 mg/dL and within the target of 100 to 179 mg/dL by hospital day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Mean FPG by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Mean FPG Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    • Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Percentage of patients achieving mean FPG range of 71 to 139 mg/dL and target of 100 to 139 mg/dL throughout the hospital study period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    • Percentage of patients achieving mean FPG range of 71 to 139 mg/dL and target of 100 to 139 mg/dL by hospital day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    • Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    • TDD of Insulin (Units/kg) Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    • TDD of Insulin (Units) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • TDD of Insulin (Units/kg) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Length of Hospital Stay Post-randomization Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
    • Incidence of hypoglycemia and severe hypoglycemia episodes, throughout hospital study period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Rate of hypoglycemia and severe hypoglycemia episodes, throughout hospital study period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Incidence of hypoglycemia and severe hypoglycemia episodes, by hospital day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Rate of hypoglycemia and severe hypoglycemia episodes, by hospital day [ Time Frame: Day 1 up to day 10 of hospital study period ]
    • Treatment-emergent adverse events throughout hospital study period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Percentage of patients requiring intensive care unit transfer [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Percentage of patients with deterioration of renal function throughout the hospital study period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Percentage of patients with documented nosocomial infections [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
    • Major adverse cardiovascular events (MACE) [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]


    Information By: Eli Lilly and Company

    Dates:
    Date Received: June 2, 2010
    Date Started: March 2011
    Date Completion:
    Last Updated: November 7, 2012
    Last Verified: November 2012