Status:
COMPLETED
Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
Primary Objective: To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by trea...
Detailed Description
The study duration for each patient is 24 weeks +/- 1 week broken down as follows: * Run-in phase: 8 weeks * Follow - up Period: 16 weeks The maximal possible time window during the study is +/- one...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Run-in period:
- Type 2 diabetes
- HbA1c≥ 8.5% (in a test of the last month)
- Age above 21 years
- Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
- Signed informed consent form
- Patients who according to their physician are eligible to the study
- Randomization:
- HbA1c \> 7.5%
- FPG \< 130 mg/dl
- Exclusion criteria:
- Type 1 diabetes
- Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
- Pregnant or breastfeeding women.
- Patients with allergy to insulin.
- Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
- Patients with mobility difficulties and/or difficulties communicating with the investigator
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01234597
Start Date
December 1 2012
End Date
April 1 2015
Last Update
July 13 2016
Active Locations (11)
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1
Investigational Site Number 376003
Beersheba, Israel
2
Investigational Site Number 376007
Haifa, Israel
3
Investigational Site Number 376004
Kfar Saba, Israel, 44281
4
Investigational Site Number 376012
Lod, Israel