Various Insulin Regimens for Diabetic Inpatients With Cir... | NCT01143948

Studies
Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

NCT01143948

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 15, 2010Estimated

Enrollment

45Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes
Liver Cirrhosis

Interventions

Glargine & Glulisine
Regular insulin
NPH & regular insulin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Apr 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

Jun 10, 2010

First Submission Date that Met QC Criteria

Jun 14, 2010

First Posted Date

Jun 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2010

Last Update Posted Date

Jun 15, 2010Estimated

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. Patients with cirrhosis & type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.

Detailed Description

Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH & regular insulin or Glargine & Glulisine.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
15 patient sliding scale regular insulin	Active Comparator	Drug: Regular insulin
15 patient BBI NPH plus regular insulin	Active Comparator	Drug: NPH & regular insulin
15 patients BBI Glargine plus Glulisine	Active Comparator	Drug: Glargine & Glulisine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glargine & Glulisine	Drug	Basal Glargine & bolus Glulisine	15 patients BBI Glargine plus Glulisine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
optimal glycemic control in inpatient cirrhotics		3-7 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of hypoglycemic episodes		3-7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized type 2 Diabetes Mellitus with liver cirrhosis
Entry blood glucose (fasting or random) greater than 180 mg%

Exclusion Criteria:

Type 1 Diabetes Mellitus
Pregnancy
Steroids: prednisone greater than 7.5mg/day or equivalent
Serum Creatinine > 3 mg/dl
Patients in intensive care units.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mostafa M Alfishawy, MB BCh	Contact	0111183371		mostafa.alfishawy@yahoo.com

Overall Officials

Name	Affiliation	Role
Ibtisam Z Eissa, MD	Cairo University	Study Chair
Mary N Rizk, MD	Cairo Univerity	Study Director
Ahmad A Khairy, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internal medicine hospital ,Cairo University		Cairo	Cairo Governorate	11956	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2037851	Background	Balkau B, Eschwege E, Ducimetiere P, Richard JL, Warnet JM. The high risk of death by alcohol related diseases in subjects diagnosed as diabetic and impaired glucose tolerant: the Paris Prospective Study after 15 years of follow-up. J Clin Epidemiol. 1991;44(6):465-74. doi: 10.1016/0895-4356(91)90209-r.
10332677	Background

ID	Term
D003924	Diabetes Mellitus, Type 2
D008103	Liver Cirrhosis
D003920	Diabetes Mellitus
D005355	Fibrosis
D007333	Insulin Resistance

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000069036	Insulin Glargine
C479079	insulin glulisine
D007328	Insulin
C557578	insulin, pork; isophane insulin, pork drug combination 30:70

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones