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

September 10, 2023 updated by: Priyathama Vellanki, Emory University

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin Aspart for BG > 140 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.

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)

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

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
Active Comparator: Insulin Aspart for BG > 260 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.

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)

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days (average time of discharge from the hospital)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days (average time of discharge from the hospital)
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.
5 days (average time of discharge from the hospital)
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.
5 days (average time of discharge from the hospital)
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.
5 days (average time of discharge from the hospital)
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.
5 days (average time of discharge from the hospital)
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.
5 days (average time of discharge from the hospital)
Mortality
Time Frame: 5 days (average time of discharge from the hospital)
The total number of subject deaths during hospital stay will be recorded.
5 days (average time of discharge from the hospital)
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.
5 days (average time of discharge from the hospital)
Mean Daily Dose of Insulin
Time Frame: 5 days (average time of discharge from the hospital)
Daily dose of insulin will be recorded
5 days (average time of discharge from the hospital)
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 days (average time of discharge from the hospital)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Priyathama Vellanki, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimated)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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