Clinical trial NCT03350984: Insulin Schemes for Type 2 Diabetes Control
Official title: Insulin Scheme for Glycemic Control in Non-critical Hospitalized Patients With Type 2 Diabetes in the Context of a Health System in Mexico.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
timeFrame: Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week
Secondary outcomes:
measure: the Number of Participants With Mild and Severe Hypoglycemic Events
timeFrame: Duration of hospital stay, up to 4 weeks.
measure: Number of Participants With Sustained Glycemic Control During Hospital Stay
timeFrame: blood glucose was taken every day, up to 4 weeks.
Other outcomes:
Locations:
city: León
country: Mexico
facility: Hospital General de León
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Jose A Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
citation: Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.
citation: Christensen MB, Gotfredsen A, Norgaard K. Efficacy of basal-bolus insulin regimens in the inpatient management of non-critically ill patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2017 Jul;33(5). doi: 10.1002/dmrr.2885. Epub 2017 Feb 23.