Clinical trial NCT02758522: NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
Official title: NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Hyperglycemia
Keywords: Diabetes Mellitus
Hospital Hyperglycemia
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Glycemic control
timeFrame: Within the time the patient stays at hospital (2 to 14 days)
Secondary outcomes:
measure: Differences in the percentage of glucoses in the hypoglycemic range
timeFrame: Within the time the patient stays at hospital (2 to 14 days)
measure: Total insulin dose required during follow up and at discharge to achieve glycemic control
timeFrame: Within the time the patient stays at hospital (2 to 14 days)
measure: Differences in hospital stay days
timeFrame: Within the time the patient stays at hospital (2 to 14 days)
Other outcomes:
Locations:
Study officials:
affiliation: Facultad de Medicina y Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Universidad Autonoma de Nuevo Leon
name: Hector E Tamez-Perez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.4158/EP.12.5.491.
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. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available.
citation: Moghissi E. Hospital management of diabetes: beyond the sliding scale. Cleve Clin J Med. 2004 Oct;71(10):801-8. doi: 10.3949/ccjm.71.10.801.
citation: 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.
citation: 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.
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.
citation: 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. doi: 10.4158/EP.12.4.458. No abstract available.
citation: Mills RD, Schwartz F, Shubrook JH. Evaluation of diabetes management in a rural community hospital. Endocr Pract. 2008 Jan-Feb;14(1):50-5. doi: 10.4158/EP.14.1.50.
citation: 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.
citation: American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.
citation: American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.