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

NCT ID: NCT01855243

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Diabetes Mellitus (DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

glargine plus supplemental glulisine

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.

Group Type: ACTIVE_COMPARATOR

Glargine

Intervention Type: DRUG

glulisine

Intervention Type: DRUG

70/30 insulin plus supplemental lunch insulin

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.

Group Type: ACTIVE_COMPARATOR

regular insulin

Intervention Type: DRUG

70/30 insulin

Intervention Type: DRUG

Sliding Scale insulin (SSI)

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

Group Type: ACTIVE_COMPARATOR

regular insulin

Intervention Type: DRUG

Interventions

regular insulin

Intervention Type: DRUG

70/30 insulin

Intervention Type: DRUG

Glargine

Intervention Type: DRUG

glulisine

Intervention Type: DRUG

Other Intervention Names

lantus; apidra

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Said

Teaching Assistant, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the department of internal medicine, Cairo University teaching hospitals,

Cairo, , Egypt

Countries

Egypt

References

Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.

Reference Type: BACKGROUND

PMID: 17513708 (View on PubMed)

Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.

Reference Type: BACKGROUND

PMID: 19017758 (View on PubMed)

Other Identifiers

CairoU teaching hospital

Identifier Type: -

Identifier Source: org_study_id