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

Emory University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin glargine; Drug: Insulin aspart; Drug: Supplemental insulin aspart

Study type: Interventional

Funder types: Other

Identifiers

NCT02408120

IRB00078695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

226 participants in 2 patient groups

Insulin Aspart for BG > 140 mg/dL

Active Comparator group

Description:

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.

Treatment:

Drug: Supplemental insulin aspart

Drug: Insulin glargine

Drug: Insulin aspart

Insulin Aspart for BG > 260 mg/dL

Active Comparator group

Description:

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.

Treatment:

Drug: Supplemental insulin aspart

Drug: Insulin glargine

Drug: Insulin aspart