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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01234597
First received: November 3, 2010
Last updated: August 14, 2014
Last verified: August 2014

November 3, 2010
August 14, 2014
December 2012
January 2015   (final data collection date for primary outcome measure)
Changes in Hemoglobin A1c (HbA1c) level [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
Changes in Hemoglobin A1c (HbA1c) level [ Time Frame: at week 28 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01234597 on ClinicalTrials.gov Archive Site
  • Rate of hypoglycemia [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Changes in insulin glargine dose [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
  • Changes in insulin glulisine dose [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
  • Changes in Fasting Blood Glucose (FBG) level [ Time Frame: At week 28 ] [ Designated as safety issue: No ]
  • Changes in Post-Prandial Glucose (PPG) level [ Time Frame: at week 28 ] [ Designated as safety issue: No ]
  • Rate of hypoglycemia [ Time Frame: From randomization to week 28 ] [ Designated as safety issue: Yes ]
  • Changes in insulin glargine dose [ Time Frame: At week 28 ] [ Designated as safety issue: No ]
  • Changes in insulin glulisine dose [ Time Frame: At week 28 ] [ Designated as safety issue: No ]
  • Changes in Oral AntiDiabetics (OADs) doses [ Time Frame: At week 28 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: INSULIN GLARGINE (HOE901)
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
  • Drug: INSULIN GLULISINE (HMR1964)
    Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
  • 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

    Interventions:
    • Drug: INSULIN GLARGINE (HOE901)
    • Drug: INSULIN GLULISINE (HMR1964)
  • 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.

    Interventions:
    • Drug: INSULIN GLARGINE (HOE901)
    • Drug: INSULIN GLULISINE (HMR1964)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2015
January 2015   (final data collection date for primary outcome measure)

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.

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01234597
LANTU_L_05146, U1111-1116-2926
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP