"Physiological" Insulin Scheme vs Traditional Scheme for Glycemic Control in Non-critical Hospitalized Patients With Diabetes Mellitus 2

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine differences in glycemic control between a traditional regimen with Neutral Protamine Hagedorn insulin (NPH) and a "physiological" regimen or basal bolus regimen with glargine and lispro insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility. Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included.

The primary outcome of the study is to determine difference in efficacy and security between the treatment groups as measured by the mean daily blood glucose (efficacy is normoglycemia and number of days in glycemic control during the hospital stay; security is hypoglycemic events and complication diabetes mellitus associated).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de Guanajuato
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Patients between 18 and 100 years old.

• History of type 2 diabetes mellitus (DM2) or that upon admission is diagnosed by values of glycated haemoglobin (HbA1) > 6.5%

• Fasting central glucose before randomization between 140mg/dl and 400mg/dl

• Non-critical patients hospitalized in the service of Internal Medicine (MI), General Surgery (CG) and Traumatology (TyO).

• Patients receiving a diabetic diet orally

• Treated with diet alone, o any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.

Exclusion Criteria:

• Parenteral nutrition

• Hyperglycemia without a known history of diabetes

• Impaired renal function (glomerular filtration rate less than 30)

• Diabetic ketoacidosis and hyperosmolar state

• Type 1 Diabetes mellitus

• Pregnancy

• Patients on treatment with more than 10mg prednisone or steroid boluses.

• Known hypopituitarism or adrenal insufficiency

• Hyperglycaemia due to stress (negative antecedent of DM2, hyperglycemia and HbA1 <6.5)

• Severe liver disease (Child-Pugh C score)

• Acute pancreatitis

• Patients with sepsis or multiple organ failure

• Candidates for intensive care unit