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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01234597
First received: November 3, 2010
Last updated: July 12, 2016
Last verified: July 2016
  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 ]

Enrollment: 219
Study Start Date: December 2012
Study Completion Date: April 2015
Primary Completion Date: April 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Investigational Site Number 376003
Beer Sheva, Israel
Investigational Site Number 376007
Haifa, Israel
Investigational Site Number 376004
Kfar Saba, Israel, 44281
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
Sachnin, Israel
Investigational Site Number 376008
Tel Aviv, Israel
Investigational Site Number 376010
Tel-Aviv, Israel
Investigational Site Number 376011
Tel-aviv, Israel
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

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: July 12, 2016
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016