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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Ukraine
Study Type
Interventional
Intervention
insulin human (HR1799)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human Insulin

Arm 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.

Outcomes

Primary Outcome Measures

Decrease of Hb A1c ≥ 1%

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2012
Last Updated
May 16, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01630369
Brief Title
Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human Insulin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
insulin human (HR1799)
Other Intervention Name(s)
Insuman Basal / Insuman Comb / Insuman Rapid
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Decrease of Hb A1c ≥ 1%
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Percentage of patients with Hb A1c < 7.5%
Time Frame
6 months
Title
Rate of hypoglycaemias (symptomatic, severe)
Time Frame
6 months
Title
Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)
Time Frame
6 months
Title
Change in FPG
Time Frame
Baseline 6 months
Title
Number of patients with adverse events
Time Frame
6 months
Title
Assessment of efficacy of education courses in Diabetes Schools
Description
Percentage of correct answers after second test compare to the testing of the initial level
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

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

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