Clinical trial NCT01234597: 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
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 219
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Hemoglobin A1c (HbA1c) level
timeFrame: Baseline, week 24
Secondary outcomes:
measure: Rate of hypoglycemia
timeFrame: Week 24
measure: Changes in insulin glargine dose
timeFrame: Baseline, week 24
measure: Changes in insulin glulisine dose
timeFrame: Baseline, week 24
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Investigational Site Number 376003
city: Haifa
country: Israel
facility: Investigational Site Number 376007
city: Kfar Saba
country: Israel
facility: Investigational Site Number 376004
city: Lod
country: Israel
facility: Investigational Site Number 376012
city: Nazareth
country: Israel
facility: Investigational Site Number 376013
city: Netanya
country: Israel
facility: Investigational Site Number 376006
city: Ramat-Gan
country: Israel
facility: Investigational Site Number 376001
city: Sachnin
country: Israel
facility: Investigational Site Number 376009
city: Tel Aviv
country: Israel
facility: Investigational Site Number 376008
city: Tel-Aviv
country: Israel
facility: Investigational Site Number 376010
city: Tel-aviv
country: Israel
facility: Investigational Site Number 376011
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: