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

Primary Purpose

Diabetes Mellitus, Hyperglycemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Once-daily Insulin
Twice-daily Insulin
Triple-daily Insulin
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Hospital Hyperglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Once-daily insulin

    Twice-daily insulin

    Triple-daily insulin

    Arm Description

    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).

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Glycemic control
    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
    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
    Differences in hospital stay days

    Full Information

    First Posted
    April 28, 2016
    Last Updated
    April 28, 2016
    Sponsor
    Hospital Universitario Dr. Jose E. Gonzalez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02758522
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario Dr. Jose E. Gonzalez

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Hyperglycemia
    Keywords
    Diabetes Mellitus, Hospital Hyperglycemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Once-daily insulin
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Twice-daily insulin
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Triple-daily insulin
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Once-daily Insulin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Twice-daily Insulin
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Triple-daily Insulin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Glycemic control
    Description
    The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of <180 mg/dL
    Time Frame
    Within the time the patient stays at hospital (2 to 14 days)
    Secondary Outcome Measure Information:
    Title
    Differences in the percentage of glucoses in the hypoglycemic range
    Description
    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.
    Time Frame
    Within the time the patient stays at hospital (2 to 14 days)
    Title
    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)
    Title
    Differences in hospital stay days
    Time Frame
    Within the time the patient stays at hospital (2 to 14 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hector E Tamez-Perez, MD, PhD
    Organizational Affiliation
    Facultad de Medicina y Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Universidad Autonoma de Nuevo Leon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17002924
    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.
    Results Reference
    background
    PubMed Identifier
    19429873
    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.
    Results Reference
    background
    PubMed Identifier
    15529485
    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.
    Results Reference
    background
    PubMed Identifier
    21041168
    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.
    Results Reference
    background
    PubMed Identifier
    19140173
    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.
    Results Reference
    background
    PubMed Identifier
    17513708
    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.
    Results Reference
    background
    PubMed Identifier
    16983798
    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.
    Results Reference
    background
    PubMed Identifier
    18238741
    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.
    Results Reference
    background
    PubMed Identifier
    19140191
    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.
    Results Reference
    background
    PubMed Identifier
    22187472
    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.
    Results Reference
    background
    PubMed Identifier
    22187469
    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.
    Results Reference
    background

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

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