Clinical trial NCT01630369: Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes
Official title: Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: 6 months

Eligibility 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.

Primary outcomes:
measure: Decrease of Hb A1c ≥ 1%
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Percentage of patients with Hb A1c < 7.5%
timeFrame: 6 months
measure: Rate of hypoglycaemias (symptomatic, severe)
timeFrame: 6 months
measure: Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)
timeFrame: 6 months
measure: Change in FPG
timeFrame: Baseline 6 months
measure: Number of patients with adverse events
timeFrame: 6 months
measure: Assessment of efficacy of education courses in Diabetes Schools
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: