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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01627509
Recruitment Status : Unknown
Verified June 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

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 or disease
Diabetes Mellitus 2 Type

Study Type : Observational
Estimated Enrollment : 40 participants
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.
Study Start Date : May 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01627509

Contact: Jacob Ilani, Dr. +97235303103
Contact: Shmuel Levit, Dr. +972508805375

The Institute of Endocrinology, Sheba Medical Center Not yet recruiting
Tel Hashomer, Gush Dan, Israel, 52621
Contact: Jacob Ilani, DR.    +97235303103   
Contact: Shmuel Levit, DR.    +972508805375   
Principal Investigator: Jacob Ilani, DR.         
Sub-Investigator: Shmuel Levit, DR.         
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Sheba Medical Center Identifier: NCT01627509     History of Changes
Other Study ID Numbers: SHEBA-10-7894-JI-CTIL
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by Sheba Medical Center:
continuous glucose monitoring system
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, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs