HyperglycemiaPhase 3HMHNCT01136746

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

A Phase 3 study testing Human regular insulin, Insulin lispro and Insulin glargine in people with Hyperglycemia, run by Eli Lilly and Company at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperglycemia
What is being tested?: Human regular insulin, Insulin lispro and Insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 12 sitesUnited States
Study dates: Mar 2011to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

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.
Atlanta, Georgia, 30312
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.
Bangor, Maine, 04401
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.
Birmingham, Alabama, 35294
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.
Charleston, South Carolina, 29425
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.
Cleveland, Ohio, 44106
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.
Hazard, Kentucky, 41701
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.
Jacksonville, Florida, 32209
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.
Kansas City, Missouri, 64111
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.
Memphis, Tennessee, 38104
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.
Miami, Florida, 33136
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.
Topeka, Kansas, 66604
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.
Weston, Florida, 33331

Other trials in United States

About this study

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

Read the 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.

Conditions: Hyperglycemia
Being tested: Human regular insulin, Insulin lispro, Insulin glargine
Keywords: Hyperglycemia, Diabetes, Hospital, Diabetic
Medical subject headings: Hyperglycemia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human regular insulinDrug
Also called Humulin R, LY041001
Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization)
Insulin lisproDrug
Also called Humalog, LY275585
Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
Insulin glargineDrug
Also called Lantus
Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)

Study groups in NCT01136746
Study group	Role	What they receive
Sliding scale regular insulin	Active comparator	Not described Receives: Drug: Human regular insulin
Basal-bolus therapy	Experimental	Not described Receives: Drug: Insulin lispro; Drug: Insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)

Secondary outcomes (26)

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.
Measured: Day 1 up to day 7 of hospital study period
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.
Measured: Day 1 up to day 10 of hospital study period
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
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.
Measured: Day 1 up to day 10 of hospital study period
Mean Fasting Plasma Glucose (FPG) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Measured: Day 1 up to day 10 of hospital study period
Mean FPG Throughout Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Measured: 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
Due to low enrollment, this outcome measure was not analyzed.
Measured: 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
Due to low enrollment, this outcome measure was not analyzed.
Measured: Day 1 up to day 10 of hospital study period
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.
Measured: Throughout the hospital study period (1 to 10 days post-randomization)
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.
Measured: Day 1 up to day 10 of hospital study period
Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Measured: Throughout the hospital study period (1 to 10 days post-randomization)
Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Measured: Day 1 up to day 10 of hospital study period
Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Measured: Throughout the hospital study period (1 to 10 days post-randomization)
TDD of Insulin (Units/kg) Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Measured: Throughout the hospital study period (1 to 10 days post-randomization)
TDD of Insulin (Units) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Measured: Day 1 up to day 10 of hospital study period
TDD of Insulin (Units/kg) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Measured: Day 1 up to day 10 of hospital study period
Length of Hospital Stay Post-randomization Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Measured: Throughout the hospital study period (1 to 10 days post-randomization)
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
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.
Measured: Day 1 up to day 10 of hospital study period
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.
Measured: Day 1 up to day 10 of hospital study period
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
Percentage of Participants Requiring Intensive Care Unit Transfer
Due to low enrollment, this outcome measure was not analyzed.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
Percentage of Participants With Documented Nosocomial Infections
Due to low enrollment, this outcome measure was not analyzed.
Measured: Throughout hospital study period (1 to 10 days post-randomization)
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.
Measured: Throughout hospital study period (1 to 10 days post-randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Nov 2011

First posted3 Jun 2010 (estimated)
Study startMar 2011
Primary completionNov 2011
Study completionNov 2011

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HyperglycemiaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01136746
Sponsor's protocol ID: 13698
Other IDs: F3Z-US-IOPZ
Acronym: HMH
Status last verified: Nov 2012
First submitted: 2 Jun 2010
Last updated: 13 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 15855602
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.
PubMed 20042772
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.
PubMed 19454396
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.
PubMed 17513708
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.
PubMed 19017758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hyperglycemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01136746
Acronym / sponsor ID: HMH / 13698
Conditions: Hyperglycemia
Keywords: Hyperglycemia, Diabetes, Hospital, Diabetic
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 16 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 3 Jun 2010 (estimated)
Results: Posted 12 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sliding scale regular insulin	Active comparator	Drug: Human regular insulin
Basal-bolus therapy	Experimental	Drug: Insulin lispro, Drug: Insulin glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Human regular insulinAlso: Humulin R, LY041001Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization)	Drug	Sliding scale regular insulin
Insulin lisproAlso: Humalog, LY275585Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)	Drug	Basal-bolus therapy
Insulin glargineAlso: LantusAdministered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)	Drug	Basal-bolus therapy

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.

26 secondary outcomes

Mean Plasma Glucose (MPG) by Hospital Day
Time frame: Day 1 up to day 7 of hospital study period
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
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)
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
Mean Fasting Plasma Glucose (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 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)
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
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)
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day
Time frame: Day 1 up to day 10 of hospital study period
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day
Time frame: Day 1 up to day 10 of hospital study period
Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Percentage of Participants Requiring Intensive Care Unit Transfer
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Percentage of Participants With Documented Nosocomial Infections
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Number of Participants With Major Adverse Cardiovascular Events (MACE)
Time frame: Throughout hospital study period (1 to 10 days post-randomization)

Results and safety

Results posted to the registry on 12 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sliding Scale Regular Insulin	9	6
Basal-bolus Therapy	7	4

Primary outcome: Mean Plasma Glucose (MPG) Throughout Hospital Study Period

Time frame: Throughout hospital study period (1 to 10 days post-randomization). Mean (Standard Deviation). Unit: milligrams per deciliter (mg/dL)

Measure	Sliding Scale Regular Insulin n = 9	Basal-bolus Therapy n = 6
Value	167.6 (48.5)	128.4 (22.4)

Population analysed: All randomized participants who had at least one post-baseline glucose measurement.

Primary outcome: 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). Number. Unit: percentage of capillary PG measurements

Measure	Sliding Scale Regular Insulin n = 9	Basal-bolus Therapy n = 6
Value	81.4	84.3

Population analysed: All randomized participants who had at least one post-baseline glucose measurement.

26 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sliding Scale Regular Insulin	1 of 9 (11.1%)	1 of 9 (11.1%)	Not reported
Basal-bolus Therapy	0 of 7 (0%)	2 of 7 (28.6%)	Not reported

Limitations and caveats (from the sponsor): Due to low enrollment, this trial was terminated early, leading to small numbers of participants analyzed or some outcome measures not being able to be analyzed at all.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15855602Workgroup 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.
Background: PubMed 20042772American 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.
Background: PubMed 19454396Moghissi 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.
Background: PubMed 17513708Umpierrez 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.
Background: PubMed 19017758Umpierrez 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human regular insulin, Insulin lispro and Insulin glargine in people with Hyperglycemia, run by Eli Lilly and Company at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Plasma Glucose (MPG) Throughout Hospital Study Period (time frame: Throughout hospital study period (1 to 10 days post-randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01136746, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2012.