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Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.

This study is currently recruiting participants.
Verified June 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01627509
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :

  • as Basal/bolus therapy (B/B) in four-five injections per day .
  • as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.

The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).


Condition
Diabetes Mellitus 2 Type

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

40 Subjects with 1 year and more of T2DM history , with two consistent HbA1C values of 7% or less - according to the blood tests within last six months.

Criteria

Major Inclusion Criteria:

  • Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist.
  • Diabetes Mellitus Type 2 history of one year at least.
  • HAb1C < 7% and less
  • Age 18-80 yrs
  • Normal Liver function tests

Major Exclusion Criteria:

  • History of substance use
  • Pregnancy or breastfeeding mothers
  • Abnormal liver or kidney functional tests
  • Type 1 Diabetes or LADA
  • any active disease ( like viral) at the period of investigation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627509

Contacts
Contact: Jacob Ilani, Dr. +97235303103 Jacob.Ilany2@sheba.health.gov.il
Contact: Shmuel Levit, Dr. +972508805375 Shlevit@gmail.com

Locations
Israel
The Institute of Endocrinology, Sheba Medical Center Not yet recruiting
Tel Hashomer, Gush Dan, Israel, 52621
Contact: Jacob Ilani, DR.     +97235303103     Jacob.Ilany2@sheba.health.gov.il    
Contact: Shmuel Levit, DR.     +972508805375     shlevit@gmail.com    
Principal Investigator: Jacob Ilani, DR.            
Sub-Investigator: Shmuel Levit, DR.            
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01627509     History of Changes
Other Study ID Numbers: SHEBA-10-7894-JI-CTIL
Study First Received: June 21, 2012
Last Updated: June 21, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
continuous glucose monitoring system
hypoglycemia
insulin regimen
 basal bolus therapy
modern premixed insulin
diabetes control

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013