Overview

Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
Summary
Primary Objective: - To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs) Secondary Objectives: - To evaluate the percentage of patients with Hb A1c < 7.5%, - To evaluate the rate of hypoglycaemia (symptomatic, severe) - To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment - To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment - To assess the overall safety - To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin, Globin Zinc
Criteria
Inclusion criteria :

- T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs

- Males and Female > 18 years

- HbA1c > 7.5%

- Patients with abilities of self-monitoring of Diabetes, managing of patient's diary,
ability to obtain education in Diabetes School, completion of Questionnaire

- It is expected that the patient will remain on a stable dose of OADs within 6 months
of treatment

Exclusion criteria :

- Type 1 diabetes

- Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery,
clinical trial)

- Any clinically significant acute major organ or systemic diseases making
interpretation of the evaluation results difficult

- Patient planning a pregnancy now or in the next 6 months

- The patient is participating in another clinical study now or in the last 28 days
prior to Visit 1

- The patient is a drug user (currently or in the past)

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.