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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)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
INSULIN GLARGINE (HOE901)
INSULIN GLULISINE (HMR1964)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 376003
  • Investigational Site Number 376007
  • Investigational Site Number 376004
  • Investigational Site Number 376012
  • Investigational Site Number 376013
  • Investigational Site Number 376006
  • Investigational Site Number 376001
  • Investigational Site Number 376009
  • Investigational Site Number 376008
  • Investigational Site Number 376010
  • Investigational Site Number 376011

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Without Continous Glucose Monitoring (CGM) sensor

Arm B: Continous Glucose Monitoring (CGM) sensor

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes in Hemoglobin A1c (HbA1c) level

Secondary Outcome Measures

Rate of hypoglycemia
Changes in insulin glargine dose
Changes in insulin glulisine dose

Full Information

First Posted
November 3, 2010
Last Updated
July 12, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01234597
Brief Title
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
Acronym
SeLan
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Without Continous Glucose Monitoring (CGM) sensor
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm B: Continous Glucose Monitoring (CGM) sensor
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE (HOE901)
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
INSULIN GLULISINE (HMR1964)
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Changes in Hemoglobin A1c (HbA1c) level
Time Frame
Baseline, week 24
Secondary Outcome Measure Information:
Title
Rate of hypoglycemia
Time Frame
Week 24
Title
Changes in insulin glargine dose
Time Frame
Baseline, week 24
Title
Changes in insulin glulisine dose
Time Frame
Baseline, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 376003
City
Beer Sheva
Country
Israel
Facility Name
Investigational Site Number 376007
City
Haifa
Country
Israel
Facility Name
Investigational Site Number 376004
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Investigational Site Number 376012
City
Lod
Country
Israel
Facility Name
Investigational Site Number 376013
City
Nazareth
Country
Israel
Facility Name
Investigational Site Number 376006
City
Netanya
Country
Israel
Facility Name
Investigational Site Number 376001
City
Ramat-Gan
Country
Israel
Facility Name
Investigational Site Number 376009
City
Sachnin
Country
Israel
Facility Name
Investigational Site Number 376008
City
Tel Aviv
Country
Israel
Facility Name
Investigational Site Number 376010
City
Tel-Aviv
Country
Israel
Facility Name
Investigational Site Number 376011
City
Tel-aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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