Insulin Schemes for Type 2 Diabetes Control

Universidad de Guanajuato

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: NPH insulin; Drug: Glargine and Lispro insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03350984

SSGTO00136

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

NPH insulin group

Experimental group

Description:

Patients receiving NPH 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. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin

Treatment:

Drug: NPH insulin

Glargine and Lispro insulin group

Active Comparator group

Description:

Half of the total of 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 will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro. Intervention drug: Glargine and Lispro

Treatment:

Drug: Glargine and Lispro insulin