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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: insulin human (HR1799)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01630369

HUBIN_L_05574

U1111-1128-8605 (Other Identifier)

Details and patient eligibility

About

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)

Full description

6 months

Enrollment: 552 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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552 participants in 1 patient group

Human Insulin

Experimental group

Description:

Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician.

Treatment:

Drug: insulin human (HR1799)