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

This study has been terminated.

(Low enrollment)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01136746

First Posted: June 3, 2010

Last Update Posted: November 13, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Eli Lilly and Company

Results First Submitted: September 12, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Hyperglycemia
Interventions:	Drug: Human regular insulin Drug: Insulin lispro Drug: Insulin glargine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sliding Scale Regular Insulin	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
Basal-bolus Therapy	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).

Description

Sliding Scale Regular Insulin

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

Basal-bolus Therapy

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

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

Participant Flow: Overall Study

	Sliding Scale Regular Insulin	Basal-bolus Therapy
STARTED	9	7
COMPLETED	6	4
NOT COMPLETED	3	3
Lost to Follow-up	0	2
Protocol Violation	2	1
Death	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Sliding Scale Regular Insulin	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
Basal-bolus Therapy	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Total	Total of all reporting groups

Description

Sliding Scale Regular Insulin

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

Basal-bolus Therapy

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

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

Total

Total of all reporting groups

Baseline Measures

	Sliding Scale Regular Insulin	Basal-bolus Therapy	Total
Overall Participants Analyzed [Units: Participants]	9	7	16

Age [Units: Years] Mean (Standard Deviation)	60.2 (16.8)	51.4 (8.5)	56.4 (14.1)

Gender [Units: Participants]
Female	5	2	7
Male	4	5	9

Ethnicity (NIH/OMB) [Units: Participants]
Hispanic or Latino	1	0	1
Not Hispanic or Latino	8	7	15
Unknown or Not Reported	0	0	0

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	2	7
White	4	5	9
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment [Units: Participants]
United States	9	7	16

Outcome Measures

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1. Primary:

Mean Plasma Glucose (MPG) Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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2. Primary:

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) ]

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3. Secondary:

Mean Plasma Glucose (MPG) by Hospital Day [ Time Frame: Day 1 up to day 7 of hospital study period ]

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4. Secondary:

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 ]

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5. Secondary:

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) ]

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6. Secondary:

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 ]

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7. Secondary:

Mean Fasting Plasma Glucose (FPG) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]

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8. Secondary:

Mean FPG Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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9. Secondary:

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) ]

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10. Secondary:

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 ]

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11. Secondary:

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) ]

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12. Secondary:

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 ]

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13. Secondary:

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) ]

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14. Secondary:

Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]

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15. Secondary:

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) ]

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16. Secondary:

TDD of Insulin (Units/kg) Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]

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17. Secondary:

TDD of Insulin (Units) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]

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18. Secondary:

TDD of Insulin (Units/kg) by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]

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19. Secondary:

Length of Hospital Stay Post-randomization Throughout the Hospital Study Period [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]

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20. Secondary:

Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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21. Secondary:

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) ]

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22. Secondary:

Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day [ Time Frame: Day 1 up to day 10 of hospital study period ]

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23. Secondary:

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 ]

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24. Secondary:

Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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25. Secondary:

Percentage of Participants Requiring Intensive Care Unit Transfer [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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26. Secondary:

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) ]

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27. Secondary:

Percentage of Participants With Documented Nosocomial Infections [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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28. Secondary:

Number of Participants With Major Adverse Cardiovascular Events (MACE) [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

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. Review.

American Diabetes Association. Standards of medical care in diabetes--2010. Diabetes Care. 2010 Jan;33 Suppl 1:S11-61. doi: 10.2337/dc10-S011. Erratum in: Diabetes Care. 2010 Mar;33(3):692.

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.

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. Epub 2007 May 18.

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.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01136746 History of Changes
Other Study ID Numbers:	13698 F3Z-US-IOPZ ( Other Identifier: Eli Lilly and Company )
First Submitted:	June 2, 2010
First Posted:	June 3, 2010
Results First Submitted:	September 12, 2012
Results First Posted:	October 12, 2012
Last Update Posted:	November 13, 2012

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