Status:

COMPLETED

Insulin Schemes for Type 2 Diabetes Control

Lead Sponsor:

Universidad de Guanajuato

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18-100 years

Phase:

PHASE4

Brief 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 Nonc...

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 requ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 2 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2018

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT03350984

Start Date

November 2 2017

End Date

July 1 2018

Last Update

December 6 2021

Active Locations (1)

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1

Hospital General de León

León, Guanajuato, Mexico, 37680