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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

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.