NCT01136746

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 12, 2012

Completed
Last Updated

November 13, 2012

Status Verified

November 1, 2012

Enrollment Period

8 months

First QC Date

June 2, 2010

Results QC Date

September 12, 2012

Last Update Submit

November 7, 2012

Conditions

Hyperglycemia

Keywords

HyperglycemiaDiabetesHospitalDiabetic

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (26)

  • Mean Plasma Glucose (MPG) by Hospital Day

    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

    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

    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

    Day 1 up to day 10 of hospital study period

  • Mean Fasting Plasma Glucose (FPG) by Hospital Day

    Day 1 up to day 10 of hospital study period

  • +21 more secondary outcomes

Study Arms (2)

Sliding scale regular insulin

ACTIVE COMPARATOR
Drug: Human regular insulin

Basal-bolus therapy

EXPERIMENTAL
Drug: Insulin lisproDrug: Insulin glargine

Interventions

Human regular insulinDRUG

Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization)

Also known as: Humulin R, LY041001
Sliding scale regular insulin
Insulin lisproDRUG

Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)

Also known as: Humalog, LY275585
Basal-bolus therapy
Insulin glargineDRUG

Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)

Also known as: Lantus
Basal-bolus therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

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, United States

Location

Related Publications (5)

  • 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.

    PMID: 15855602BACKGROUND

  • 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.

    PMID: 20042772BACKGROUND

  • 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.

    PMID: 19454396BACKGROUND

  • 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.

    PMID: 17513708BACKGROUND

  • 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.

    PMID: 19017758BACKGROUND

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus

Interventions

InsulinInsulin LisproInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-ActingInsulin, Long-Acting

Limitations and Caveats

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.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 13, 2012

Results First Posted

October 12, 2012

Record last verified: 2012-11

Locations

US(12)