Clinical trial NCT02408120: Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Official title: Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Hyperglycemia
Hypoglycemia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean Daily BG Levels
timeFrame: 5 days (average time of discharge from the hospital)
Secondary outcomes:
measure: Mean Blood Glucose Levels Before Lunch
timeFrame: 5 days (average time of discharge from the hospital)
measure: Mean Blood Glucose Levels at Bedtime
timeFrame: 5 days (average time of discharge from the hospital)
measure: Mean Blood Glucose Levels Before Dinner
timeFrame: 5 days (average time of discharge from the hospital)
measure: Number of Hypoglycemia Events
timeFrame: 5 days (average time of discharge from the hospital)
measure: Incidence of Hyperglycemia
timeFrame: 5 days (average time of discharge from the hospital)
measure: Number of Blood Glucose Readings Within 100-140 mg/dL Range
timeFrame: 5 days (average time of discharge from the hospital)
measure: Average Number of Days of Hospital Stay
timeFrame: 5 days (average time of discharge from the hospital)
measure: Mortality
timeFrame: 5 days (average time of discharge from the hospital)
measure: Number of Subjects That Experienced Hospital Complications
timeFrame: 5 days (average time of discharge from the hospital)
measure: Mean Daily Dose of Insulin
timeFrame: 5 days (average time of discharge from the hospital)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Priyathama Vellanki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vellanki P, Cardona S, Galindo RJ, Urrutia MA, Pasquel FJ, Davis GM, Fayfman M, Migdal A, Peng L, Umpierrez GE. Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study. Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606.