- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408120
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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:
Other Names:
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:
Other Names:
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:
For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:
Other Names:
|
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:
Other Names:
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:
Other Names:
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:
For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:
Other Names:
|
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)
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The blood glucose levels will be assessed prior to lunch using a glucose meter.
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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)
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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)
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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)
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The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded.
|
5 days (average time of discharge from the hospital)
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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)
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Average Number of Days of Hospital Stay
Time Frame: 5 days (average time of discharge from the hospital)
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The average number of days in the hospital for subjects will be calculated.
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5 days (average time of discharge from the hospital)
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Mortality
Time Frame: 5 days (average time of discharge from the hospital)
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The total number of subject deaths during hospital stay will be recorded.
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5 days (average time of discharge from the hospital)
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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)
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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
Sponsor
Investigators
- Principal Investigator: Priyathama Vellanki, MD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hyperglycemia
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Insulin Glargine
Other Study ID Numbers
- IRB00078695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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