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

NCT01855243 | Completed Results

• 1 other identifier: CairoU teaching hospital
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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)

Keywords

Type 2 D M; sliding scale insulin; 70/30 insulin; basals insulin; supplemental insulin

Outcome Measures

Primary Outcomes (2)

• Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.

  during hospital stay which is expected to be average 3 weeks

• Mean BG After First Day of Hospitalization

  after first day of hospitalization

Secondary Outcomes (3)

• Number of Patients Developed Hypoglycemic Events

  during hospital stay which is expected to be average 3 weeks

• Number of Patients Developed Episodes of Severe Hyperglycemia

  during hospital stay which is expected to be average 3 weeks

• Mortality Rate

  during the hospital stay which is expected to be average 3 weeks

Study Arms (3)

glargine plus supplemental glulisine

ACTIVE COMPARATOR

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.

Drug: Glargine; Drug: glulisine

70/30 insulin plus supplemental lunch insulin

ACTIVE COMPARATOR

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.

Drug: regular insulin; Drug: 70/30 insulin

Sliding Scale insulin (SSI)

ACTIVE COMPARATOR

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

Drug: regular insulin

Interventions

regular insulin DRUG

70/30 insulin plus supplemental lunch insulin; Sliding Scale insulin (SSI)

70/30 insulin DRUG

70/30 insulin plus supplemental lunch insulin

Glargine DRUG

Also known as: lantus

glargine plus supplemental glulisine

glulisine DRUG

Also known as: apidra

glargine plus supplemental glulisine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

the department of internal medicine, Cairo University teaching hospitals,

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 17513708 BACKGROUND

• 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.

  PMID: 19017758 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin; Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Limitations and Caveats

self funded

Results Point of Contact

• Title: Eman Said Sayed
• Organization: Cairo University

gaviota_3011@hotmail.com

01001186079

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, Cairo University

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 16, 2013
• Study Start: March 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2018-07

Locations

EG (1)