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

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.

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)

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: insulin human (HR1799)

Detailed Description

6 months

• Study Type: Interventional
• Enrollment (Actual): 552
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Insulin; 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.	Drug: insulin human (HR1799); Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: Insuman Basal / Insuman Comb / Insuman Rapid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease of Hb A1c ≥ 1%	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events		6 months
Percentage of patients with Hb A1c < 7.5%		6 months
Rate of hypoglycaemias (symptomatic, severe)		6 months
Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)		6 months
Change in FPG		Baseline 6 months
Assessment of efficacy of education courses in Diabetes Schools	Percentage of correct answers after second test compare to the testing of the initial level	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): May 19, 2014
• Last Update Submitted That Met QC Criteria: May 16, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: HUBIN_L_05574; U1111-1128-8605 (Other Identifier: UTN)