Insulin Schemes for Type 2 Diabetes Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      On the first 4 to 6 h, the use of NPH insulin present a pronounced action peak on the
      postprandial glucose metabolism, and the rest of its basal action last 12 to 18 h, its cover
      the postprandial requirements of the first two meals of the day (breakfast and lunch)
      administering 2/3 of the total dose, and the requirements for the dinner with 1/3 of the
      total dose at the night. This is considered a good scheme for handling hyperglycemia, and its
      possible to have less hypoglycemia episodes, which are possible if an ultra-rapid-acting
      insulin is added and adequate intake is not performed due to multiple factors related to
      hospitalization.

      Today it is uncertain whether there is any clear benefit of using Glargine plus Lantus
      insulin over NPH insulin in hospitalized patients with type 2 diabetes. Currently, both
      Glargine and NPH based regimen is practiced in inpatient hospital facilities. Current
      practice of inpatient insulin regimen is based on the physicians familiarity with a
      particular insulin type and personal preference rather than evidenced based knowledge.
      Glargine plus ultrafast insulin are two types of insulin that are more expensive compared to
      NPH with incidental benefits in hospitalized patients. There are reports in the literature
      about the incidence of hypoglycemia with this scheme. The current research proposal is to
      compare these two schemes in the treatment of hospitalized patients with diabetes in a
      hospital of the second level of care in Mexico.
    

Intervention name(s): NPH insulin; Glargine and Lispro insulin
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): NPH; Glargine and Lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment