Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

Cairo University (CU)

Status: Completed

Conditions: Diabetes Mellitus (DM)

Treatments: Drug: 70/30 insulin; Drug: Glargine; Drug: glulisine; Drug: regular insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01855243

CairoU teaching hospital

Details and patient eligibility

About

Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.

Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.

Enrollment: 63 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• known history of type 2 DM for longer than 3 months
• age between 18-64 year old,
• treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.

Exclusion criteria

• subjects with hyperglycemia without any known history of DM
• presence of diabetic ketoacidosis (DKA)
• patients admitted to intensive care unit (ICU)
• subjects expected to undergo surgery during the hospitalization course
• patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

glargine plus supplemental glulisine

Active Comparator group

Description:

Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held.

Treatment:

Drug: glulisine

Drug: Glargine

70/30 insulin plus supplemental lunch insulin

Active Comparator group

Description:

Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home.

Treatment:

Drug: regular insulin

Drug: 70/30 insulin

Sliding Scale insulin (SSI)

Active Comparator group

Description:

For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table

Treatment:

Drug: regular insulin