Insulin Schemes for Type 2 Diabetes Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: NPH insulin; Glargine and Lispro insulin
Intervention description: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL.; Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The aim of the study is to determine differences in glycemic control between a basal-bolus
      scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2
      diabetes in a Noncritical Care Facility in Mexico. 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
      a basal-bolus scheme insulin and NPH scheme insulin in patients with type 2 diabetes
      hospitalized in non-critical areas in a hospital in Mexico
    

Eligibility 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