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

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Insulin glargine
Drug: Insulin aspart
Drug: Supplemental insulin aspart

Registration Number: NCT02408120

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 226

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Aspart for BG > 140 mg/dL	Supplemental insulin aspart	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.
Insulin Aspart for BG > 260 mg/dL	Supplemental insulin aspart	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.
Insulin Aspart for BG > 140 mg/dL	Insulin glargine	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.
Insulin Aspart for BG > 140 mg/dL	Insulin aspart	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.
Insulin Aspart for BG > 260 mg/dL	Insulin glargine	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.
Insulin Aspart for BG > 260 mg/dL	Insulin aspart	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.

Primary Outcome Measures

Name	Time	Method
Mean Daily BG Levels	5 days (average time of discharge from the hospital)	Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.

Secondary Outcome Measures

Name	Time	Method
Mean Blood Glucose Levels at Bedtime	5 days (average time of discharge from the hospital)	The blood glucose levels will be assessed at bedtime using a glucose meter.
Mean Blood Glucose Levels Before Dinner	5 days (average time of discharge from the hospital)	The blood glucose levels will be assessed before dinner using a glucose meter.
Mean Blood Glucose Levels Before Lunch	5 days (average time of discharge from the hospital)	The blood glucose levels will be assessed prior to lunch using a glucose meter.
Number of Hypoglycemia Events	5 days (average time of discharge from the hospital)	The number of occurrences of hypoglycemia (blood glucose levels \< 70 mg/dL) will be recorded.
Average Number of Days of Hospital Stay	5 days (average time of discharge from the hospital)	The average number of days in the hospital for subjects will be calculated.
Number of Blood Glucose Readings Within 100-140 mg/dL Range	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.
Incidence of Hyperglycemia	5 days (average time of discharge from the hospital)	The number of occurrences of hyperglycemia (blood glucose levels \> 260 mg/dL) will be recorded.
Mortality	5 days (average time of discharge from the hospital)	The total number of subject deaths during hospital stay will be recorded.
Number of Subjects That Experienced Hospital Complications	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.
Mean Daily Dose of Insulin	5 days (average time of discharge from the hospital)	Daily dose of insulin will be recorded