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 currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01234597
First received: November 3, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE (HOE901)
Drug: INSULIN GLULISINE (HMR1964)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Changes in Hemoglobin A1c (HbA1c) level [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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.

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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234597

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
Israel
Investigational Site Number 376003 Recruiting
Beer Sheva, Israel, 84101
Investigational Site Number 376005 Recruiting
Beer Yaakov, Israel
Investigational Site Number 376001 Recruiting
Ramat-Gan, Israel
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01234597     History of Changes
Other Study ID Numbers: LANTU_L_05146, U1111-1116-2926
Study First Received: November 3, 2010
Last Updated: April 14, 2014
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014