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OpenTrials
Completed

NCT Number: NCT01855243

Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.

Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.

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Key information

Conditions

Diabetes Mellitus (DM) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the department of internal medicine, Cairo University teaching hospitals,

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • known history of type 2 DM for longer than 3 months
  • age between 18-64 year old,
  • treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.

Exclusion criteria

  • subjects with hyperglycemia without any known history of DM
  • presence of diabetic ketoacidosis (DKA)
  • patients admitted to intensive care unit (ICU)
  • subjects expected to undergo surgery during the hospitalization course
  • patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing

Treatment and study plan

Regular insulin

Drug

70/30 insulin

Drug

Glargine

Drug

Other names: lantus

Glulisine

Drug

Other names: apidra

Primary outcomes

  1. Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.

    Time frame: during hospital stay which is expected to be average 3 weeks

  2. Mean BG After First Day of Hospitalization

    Time frame: after first day of hospitalization

Secondary outcomes

  1. Number of Patients Developed Hypoglycemic Events

    Time frame: during hospital stay which is expected to be average 3 weeks

    Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events.

  2. Number of Patients Developed Episodes of Severe Hyperglycemia

    Time frame: during hospital stay which is expected to be average 3 weeks

    Hyperglycemic events are defined as BG > 300 mg/dL.

  3. Mortality Rate

    Time frame: during the hospital stay which is expected to be average 3 weeks

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Premix 70/30 Insulin Plus Supplemental Lunch Insulin in Comparison to Basal Plus Prandial Supplemental Scale and Sliding Scale Insulin in Hospitalized Patients With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 16, 2013
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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