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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) Phase 4 219

Completed
Clinical Trial NCT01234597 (SeLan) was designed to study Treatment for Diabetes Mellitus, Type 2. This was a Phase 4 interventional study that is now completed. The study started on December 1, 2012, with plans to enroll 219 participants. Led by Sanofi, the expected completion date was April 1, 2015. The latest data from ClinicalTrials.gov was last updated on July 13, 2016.
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 treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen

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.

Official Title

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

Conditions
Diabetes Mellitus, Type 2
Other Study IDs
  • SeLan
  • LANTU_L_05146
  • U1111-1116-2926 (Other Identifier) (UTN)
NCT ID Number
NCT01234597
Start Date (Actual)
2012-12
Last Update Posted
2016-07-13
Completion Date (Estimated)
2015-04
Enrollment (Estimated)
219
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorArm 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
INSULIN GLARGINE (HOE901)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
INSULIN GLULISINE (HMR1964)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
ExperimentalArm 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...Show More
INSULIN GLARGINE (HOE901)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
INSULIN GLULISINE (HMR1964)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Changes in Hemoglobin A1c (HbA1c) level
Baseline, week 24
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of hypoglycemia
Week 24
Changes in insulin glargine dose
Baseline, week 24
Changes in insulin glulisine dose
Baseline, week 24
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
All

Run-in period:

  1. Type 2 diabetes
  2. HbA1c≥ 8.5% (in a test of the last month)
  3. Age above 21 years
  4. Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
  5. Signed informed consent form
  6. Patients who according to their physician are eligible to the study

Randomization:

  1. HbA1c > 7.5%
  2. FPG < 130 mg/dl

  1. Type 1 diabetes
  2. Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
  3. Pregnant or breastfeeding women.
  4. Patients with allergy to insulin.
  5. Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
  6. 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.

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11 Study Locations in 1 Countries
Investigational Site Number 376003, Beersheba, Israel
Investigational Site Number 376007, Haifa, Israel
Investigational Site Number 376004, Kfar Saba, 44281, Israel
Investigational Site Number 376012, Lod, Israel
Investigational Site Number 376013, Nazareth, Israel
Investigational Site Number 376006, Netanya, Israel
Investigational Site Number 376001, Ramat Gan, Israel
Investigational Site Number 376009, Sakhnin, Israel
Investigational Site Number 376008, Tel Aviv, Israel
Investigational Site Number 376010, Tel Aviv, Israel
Investigational Site Number 376011, Tel Aviv, Israel