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

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ClinicalTrials.gov Identifier: NCT02408120
Recruitment Status : Recruiting
First Posted : April 3, 2015
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Priyathama Vellanki, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin glargine Drug: Insulin aspart Drug: Supplemental insulin aspart Phase 4

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.
Drug: Insulin glargine

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 Name: Lantus (glargine)

Drug: Insulin aspart

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 Name: Novolog

Drug: Supplemental insulin aspart

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 Name: 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.
Drug: Insulin glargine

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 Name: Lantus (glargine)

Drug: Insulin aspart

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 Name: Novolog

Drug: Supplemental insulin aspart

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 Name: Novolog




Primary Outcome Measures :
  1. Change in mean daily blood glucose levels [ Time Frame: Screening, 5 days (average time of discharge from the hospital) ]
    Blood glucose (BG) will be measured at screening and at the time of discharge in patients receiving insulin supplementation for correction of hyperglycemia (BG >140 mg/dL) compared to those without insulin supplementation using a glucose meter. Change is the difference between the discharge blood glucose and screening blood glucose. Subjects that receive insulin supplementation for correction of severe hyperglycemia (BG >260 mg/dL) are excluded from this outcome measure.


Secondary Outcome Measures :
  1. Mean blood glucose levels before meals [ Time Frame: 5 days (average time of discharge from the hospital) ]
    The blood glucose levels will be assessed prior to each meal 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 at 3:00 AM [ Time Frame: 5 days (average time of discharge from the hospital) ]
    The blood glucose levels will be assessed at 3:00 AM using a glucose meter.

  4. Incidence of hypoglycemia [ 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. Hypoglycemia Symptom Assessment Scores [ Time Frame: 5 days (average time of discharge from the hospital) ]
    The typical symptoms of hypoglycemia,e.g. sweating, tremulousness, hunger, and/or dizziness, loss of consciousness or other major alteration of mental status will be assessed using the Hypoglycemia Symptom Score Questionnaire post event. The score for each item on the Stanford hypoglycemia questionnaire ranges from 0-7. Higher total scores indicate more hypoglycemic symptoms.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408120


Contacts
Contact: Priyathama Vellanki, MD (404) 778 1687 priyathama.vellanki@emory.edu

Locations
United States, Georgia
Grady Memorial Hospital Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: Priyathama Vellanki, MD    404-778-1687    priyathama.vellanki@emory.edu   
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Priyathama Vellanki, MD    404-778-1687    priyathama.vellanki@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Priyathama Vellanki, MD Emory University

Responsible Party: Priyathama Vellanki, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02408120     History of Changes
Other Study ID Numbers: IRB00078695
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Priyathama Vellanki, Emory University:
Hyperglycemia
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs