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)

July 12, 2016 updated by: Sanofi

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

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

Interventional

Enrollment (Actual)

219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Sachnin, Israel
        • Investigational Site Number 376009
      • Tel Aviv, Israel
        • Investigational Site Number 376008
      • Tel-Aviv, Israel
        • Investigational Site Number 376010
      • Tel-aviv, Israel
        • Investigational Site Number 376011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on INSULIN GLARGINE (HOE901)

Subscribe