NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens

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ClinicalTrials.gov Identifier: NCT02758522

Recruitment Status : Completed

First Posted : May 2, 2016

Last Update Posted : May 2, 2016

Sponsor:

Information provided by (Responsible Party):

Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez

Study Description

Brief Summary:

The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus Hyperglycemia	Drug: Once-daily Insulin Drug: Twice-daily Insulin Drug: Triple-daily Insulin	Phase 4

Detailed Description:

Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	105 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
Study Start Date :	October 2013
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Once-daily insulin 60% of total dose of insulin as NPH insulin in the once-daily regimen was administered subcutaneously before breakfast. Also, 40% in rapid insulin before meals (every 8 hours).	Drug: Once-daily Insulin Patients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.
Active Comparator: Twice-daily insulin 60% of total dose of insulin as NPH insulin in the twice-daily regimen it was given before breakfast and before dinner. Also, 40% in rapid insulin before meals (every 8 hours).	Drug: Twice-daily Insulin Patients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.
Active Comparator: Triple-daily insulin 60% of total dose of insulin as NPH insulin in the triple daily regimen it was administered before each meal. Also, 40% in rapid insulin before meals (every 8 hours).	Drug: Triple-daily Insulin Patients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.

Outcome Measures

Primary Outcome Measures :

Glycemic control [ Time Frame: Within the time the patient stays at hospital (2 to 14 days) ]
The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of <180 mg/dL

Secondary Outcome Measures :

Differences in the percentage of glucoses in the hypoglycemic range [ Time Frame: Within the time the patient stays at hospital (2 to 14 days) ]
Hypoglycemia was defined as glucose levels of < 70 mg/dL. Severe hypoglycemia was defined as glucose levels of < 40 mg/dL or the need of assistance.
Total insulin dose required during follow up and at discharge to achieve glycemic control [ Time Frame: Within the time the patient stays at hospital (2 to 14 days) ]
Differences in hospital stay days [ Time Frame: Within the time the patient stays at hospital (2 to 14 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Admitted to medical services
Persistent blood glucose level > 140 mg/dL
With an expected stay ≥ 48 hours

Exclusion Criteria:

Subjects with type 1 diabetes mellitus
Parenteral nutrition
Glucose levels ≥ 400 mg/dL at screening
Diabetic ketoacidosis or non-ketosis hyperosmolar state
Clinically relevant hepatic disease
Glomerular filtration rate ≤ 30 ml/min
Pregnancy
Terminal disease
Inability to provide informed consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758522

Sponsors and Collaborators

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

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Principal Investigator:	Hector E Tamez-Perez, MD, PhD	Facultad de Medicina y Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Universidad Autonoma de Nuevo Leon

More Information

Publications:

DeSantis AJ, Schmeltz LR, Schmidt K, O'Shea-Mahler E, Rhee C, Wells A, Brandt S, Peterson S, Molitch ME. Inpatient management of hyperglycemia: the Northwestern experience. Endocr Pract. 2006 Sep-Oct;12(5):491-505.

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. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8.

Moghissi E. Hospital management of diabetes: beyond the sliding scale. Cleve Clin J Med. 2004 Oct;71(10):801-8. Review.

Pichardo-Lowden AR, Fan CY, Gabbay RA. Management of hyperglycemia in the non-intensive care patient: featuring subcutaneous insulin protocols. Endocr Pract. 2011 Mar-Apr;17(2):249-60. doi: 10.4158/EP10220.RA. Review.

Maynard G, Lee J, Phillips G, Fink E, Renvall M. Improved inpatient use of basal insulin, reduced hypoglycemia, and improved glycemic control: effect of structured subcutaneous insulin orders and an insulin management algorithm. J Hosp Med. 2009 Jan;4(1):3-15. doi: 10.1002/jhm.391.

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.

ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association consensus statement on inpatient diabetes and glycemic control. Endocr Pract. 2006 Jul-Aug;12(4):458-68. Review.

Mills RD, Schwartz F, Shubrook JH. Evaluation of diabetes management in a rural community hospital. Endocr Pract. 2008 Jan-Feb;14(1):50-5.

Schnipper JL, Ndumele CD, Liang CL, Pendergrass ML. Effects of a subcutaneous insulin protocol, clinical education, and computerized order set on the quality of inpatient management of hyperglycemia: results of a clinical trial. J Hosp Med. 2009 Jan;4(1):16-27. doi: 10.1002/jhm.385.

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1:S64-71. doi: 10.2337/dc12-s064.

American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1:S11-63. doi: 10.2337/dc12-s011. Review.

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Responsible Party:	Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:	NCT02758522
Other Study ID Numbers:	MI13-005
First Posted:	May 2, 2016 Key Record Dates
Last Update Posted:	May 2, 2016
Last Verified:	April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez:


Diabetes Mellitus Hospital Hyperglycemia

Additional relevant MeSH terms:

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Diabetes Mellitus Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Insulin Insulin, Globin Zinc Hypoglycemic Agents Physiological Effects of Drugs

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