search
Back to results

Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin (HMH)

Primary Purpose

Hyperglycemia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Human regular insulin
Insulin lispro
Insulin glargine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring Hyperglycemia, Diabetes, Hospital, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  • No known history of diabetes
  • Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL
  • Non-critically ill and admitted to acute care medical services
  • Have a body mass index greater than or equal to 18.5 kg/m^2 and less than or equal to 45 kilograms per square meter (kg/m^2)

Major Exclusion Criteria:

  • Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization
  • Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL
  • Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry
  • Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period
  • Expected hospitalization less than 24 hours post-randomization

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sliding scale regular insulin

Basal-bolus therapy

Arm Description

Outcomes

Primary Outcome Measures

Mean Plasma Glucose (MPG) Throughout Hospital Study Period
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
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.

Secondary Outcome Measures

Mean Plasma Glucose (MPG) by Hospital Day
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
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
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
Due to low enrollment, this outcome measure was not analyzed.
Mean Fasting Plasma Glucose (FPG) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Mean FPG Throughout Hospital Study Period
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
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
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
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
Due to low enrollment, this outcome measure was not analyzed.
Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
TDD of Insulin (Units/kg) Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
TDD of Insulin (Units) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
TDD of Insulin (Units/kg) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Length of Hospital Stay Post-randomization Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period
Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.
Percentage of Participants Requiring Intensive Care Unit Transfer
Due to low enrollment, this outcome measure was not analyzed.
Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period
Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.
Percentage of Participants With Documented Nosocomial Infections
Due to low enrollment, this outcome measure was not analyzed.
Number of Participants With Major Adverse Cardiovascular Events (MACE)
MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.

Full Information

First Posted
June 2, 2010
Last Updated
November 7, 2012
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01136746
Brief Title
Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin
Acronym
HMH
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-Critically Ill Patients Without Known History of Diabetes: The HMH Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Hyperglycemia, Diabetes, Hospital, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sliding scale regular insulin
Arm Type
Active Comparator
Arm Title
Basal-bolus therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Human regular insulin
Other Intervention Name(s)
Humulin R, LY041001
Intervention Description
Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization)
Intervention Type
Drug
Intervention Name(s)
Insulin lispro
Other Intervention Name(s)
Humalog, LY275585
Intervention Description
Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
Primary Outcome Measure Information:
Title
Mean Plasma Glucose (MPG) Throughout Hospital Study Period
Description
Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period
Description
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.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Secondary Outcome Measure Information:
Title
Mean Plasma Glucose (MPG) by Hospital Day
Description
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.
Time Frame
Day 1 up to day 7 of hospital study period
Title
Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
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
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
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
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Mean Fasting Plasma Glucose (FPG) by Hospital Day
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Mean FPG Throughout Hospital Study Period
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
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
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout the hospital study period (1 to 10 days post-randomization)
Title
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
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
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
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout the hospital study period (1 to 10 days post-randomization)
Title
Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout the hospital study period (1 to 10 days post-randomization)
Title
Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout the hospital study period (1 to 10 days post-randomization)
Title
TDD of Insulin (Units/kg) Throughout the Hospital Study Period
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout the hospital study period (1 to 10 days post-randomization)
Title
TDD of Insulin (Units) by Hospital Day
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
TDD of Insulin (Units/kg) by Hospital Day
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Length of Hospital Stay Post-randomization Throughout the Hospital Study Period
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout the hospital study period (1 to 10 days post-randomization)
Title
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period
Description
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period
Description
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day
Description
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day
Description
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Day 1 up to day 10 of hospital study period
Title
Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period
Description
Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Percentage of Participants Requiring Intensive Care Unit Transfer
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period
Description
Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Percentage of Participants With Documented Nosocomial Infections
Description
Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)
Title
Number of Participants With Major Adverse Cardiovascular Events (MACE)
Description
MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.
Time Frame
Throughout hospital study period (1 to 10 days post-randomization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria: No known history of diabetes Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL Non-critically ill and admitted to acute care medical services Have a body mass index greater than or equal to 18.5 kg/m^2 and less than or equal to 45 kilograms per square meter (kg/m^2) Major Exclusion Criteria: Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period Expected hospitalization less than 24 hours post-randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15855602
Citation
Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
Results Reference
background
PubMed Identifier
20042772
Citation
American Diabetes Association. Standards of medical care in diabetes--2010. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc10-S011. No abstract available. Erratum In: Diabetes Care. 2010 Mar;33(3):692.
Results Reference
background
PubMed Identifier
19454396
Citation
Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Endocr Pract. 2009 May-Jun;15(4):353-69. doi: 10.4158/EP09102.RA. No abstract available.
Results Reference
background
PubMed Identifier
17513708
Citation
Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
Results Reference
background
PubMed Identifier
19017758
Citation
Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs