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

Type 2 Diabetes Mellitus Clinical Trial

— SPIRIT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630369
• Other study ID #: HUBIN_L_05574
• Secondary ID: U1111-1128-8605
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2012
• Last updated: May 16, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

Description:

6 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• insulin human (HR1799)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Ukraine	Sanofi-Aventis Administrative Office	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of Hb A1c = 1%		Baseline, 6 months	No
Secondary	Percentage of patients with Hb A1c < 7.5%		6 months	No
Secondary	Rate of hypoglycaemias (symptomatic, severe)		6 months	Yes
Secondary	Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)		6 months	No
Secondary	Change in FPG		Baseline 6 months	No
Secondary	Number of patients with adverse events		6 months	Yes
Secondary	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	No