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. (SPIRIT)

NCT01630369 Phase 4 COMPLETED

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)

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	552
Start date	2012-02
Completion	2013-05

Conditions

• Type 2 Diabetes Mellitus

Interventions

• insulin human (HR1799)

Primary outcomes

• Decrease of Hb A1c ≥ 1% — Baseline, 6 months

Countries

Ukraine