- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01234597
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 (SeLan)
A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
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 treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
Study Overview
Status
Conditions
Intervention / Treatment
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 week throughout the study.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Beer Sheva, Israel
- Investigational Site Number 376003
-
Haifa, Israel
- Investigational Site Number 376007
-
Kfar Saba, Israel, 44281
- Investigational Site Number 376004
-
Lod, Israel
- Investigational Site Number 376012
-
Nazareth, Israel
- Investigational Site Number 376013
-
Netanya, Israel
- Investigational Site Number 376006
-
Ramat-Gan, Israel
- Investigational Site Number 376001
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Sachnin, Israel
- Investigational Site Number 376009
-
Tel Aviv, Israel
- Investigational Site Number 376008
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Tel-Aviv, Israel
- Investigational Site Number 376010
-
Tel-aviv, Israel
- Investigational Site Number 376011
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A: Without Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician |
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
|
Experimental: Arm B: Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. |
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Hemoglobin A1c (HbA1c) level
Time Frame: Baseline, week 24
|
Baseline, week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of hypoglycemia
Time Frame: Week 24
|
Week 24
|
Changes in insulin glargine dose
Time Frame: Baseline, week 24
|
Baseline, week 24
|
Changes in insulin glulisine dose
Time Frame: Baseline, week 24
|
Baseline, week 24
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LANTU_L_05146
- U1111-1116-2926 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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