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NCT Number: NCT02408120

Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
  • Known history of Type 2 diabetes mellitus for >3 months
  • Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
  • Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis

Exclusion criteria

  • Hyperglycemia without a history of diabetes
  • Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
  • Subjects receiving continuous insulin infusion
  • Clinically relevant hepatic disease
  • Corticosteroid therapy
  • Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30
  • Subjects unable to sign consent
  • Pregnancy

Treatment and study plan

insulin glargine

Drug

Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day.

Daily insulin dose will be adjusted as follow:

  • If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
  • If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
  • If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
  • If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
  • If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.

Other names: Lantus (glargine)

insulin aspart

Drug

Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held.

Daily insulin dose will be adjusted as follow:

  • If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
  • If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
  • If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
  • If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
  • If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.

Other names: Novolog

Supplemental insulin aspart

Drug

Insulin aspart will be administered following the supplemental insulin scale protocol.

For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:

  • BG >141-180 mg/dL; 2-4 units of insulin aspart
  • BG between 181-220 mg/dL; 3-6 units of insulin aspart
  • BG between 221-260 mg/dL; 4-8 units of insulin aspart
  • BG between 261-300 mg/dL; 5-10 units of insulin aspart
  • BG between 301-350 mg/dL; 6-12 units of insulin aspart
  • BG between 351-400 mg/dL; 7-14 units of insulin aspart
  • BG > 400 mg/dL; 8-16 units of insulin aspart

For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:

  • BG between 261-300 mg/dL; 5-10 units of insulin aspart
  • BG between 301-350 mg/dL; 6-12 units of insulin aspart
  • BG between 351-400 mg/dL; 7-14 units of insulin aspart
  • BG > 400 mg/dL; 8-16 units of insulin aspart

Other names: Novolog

Primary outcomes

  1. Mean Daily BG Levels

    Time frame: 5 days (average time of discharge from the hospital)

    Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.

Secondary outcomes

  1. Mean Blood Glucose Levels Before Lunch

    Time frame: 5 days (average time of discharge from the hospital)

    The blood glucose levels will be assessed prior to lunch using a glucose meter.

  2. Mean Blood Glucose Levels at Bedtime

    Time frame: 5 days (average time of discharge from the hospital)

    The blood glucose levels will be assessed at bedtime using a glucose meter.

  3. Mean Blood Glucose Levels Before Dinner

    Time frame: 5 days (average time of discharge from the hospital)

    The blood glucose levels will be assessed before dinner using a glucose meter.

  4. Number of Hypoglycemia Events

    Time frame: 5 days (average time of discharge from the hospital)

    The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.

  5. Incidence of Hyperglycemia

    Time frame: 5 days (average time of discharge from the hospital)

    The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded.

  6. Number of Blood Glucose Readings Within 100-140 mg/dL Range

    Time frame: 5 days (average time of discharge from the hospital)

    The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.

  7. Average Number of Days of Hospital Stay

    Time frame: 5 days (average time of discharge from the hospital)

    The average number of days in the hospital for subjects will be calculated.

  8. Mortality

    Time frame: 5 days (average time of discharge from the hospital)

    The total number of subject deaths during hospital stay will be recorded.

  9. Number of Subjects That Experienced Hospital Complications

    Time frame: 5 days (average time of discharge from the hospital)

    The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.

  10. Mean Daily Dose of Insulin

    Time frame: 5 days (average time of discharge from the hospital)

    Daily dose of insulin will be recorded

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2015
Registry last updated
Sep 28, 2023

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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