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

NCT ID: NCT01627509

Last Updated: 2012-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus 2 Type

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Institute of Endocrinology, Sheba Medical Center

Tel Litwinsky, Gush Dan, Israel

Site Status NOT_YET_RECRUITING

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Jacob Ilani, Dr.

Role: CONTACT

+97235303103

Shmuel Levit, Dr.

Role: CONTACT

+972508805375

Facility Contacts

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Jacob Ilani, DR.

Role: primary

+97235303103

Shmuel Levit, DR.

Role: backup

+972508805375

Other Identifiers

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SHEBA-10-7894-JI-CTIL

Identifier Type: -

Identifier Source: org_study_id

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