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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01630369
First received: June 26, 2012
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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)

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: insulin human (HR1799)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open, Non-randomized Study on Evaluation of Efficacy and Safety of Insuman® Basal, Insuman ®Comb 25, Insuman ®Rapid in Patients With Type 2 Diabetes, Who Received Baseline Education Course in Diabetes School.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Decrease of Hb A1c ≥ 1% [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with Hb A1c < 7.5% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Rate of hypoglycaemias (symptomatic, severe) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in FPG [ Time Frame: Baseline 6 months ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Assessment of efficacy of education courses in Diabetes Schools [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Percentage of correct answers after second test compare to the testing of the initial level


Estimated Enrollment: 558
Study Start Date: February 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Insuman Basal / Insuman Comb / Insuman Rapid

Detailed Description:

6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630369

Locations
Ukraine
Sanofi-Aventis Administrative Office
Kyiv, Ukraine
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01630369     History of Changes
Other Study ID Numbers: HUBIN_L_05574, U1111-1128-8605
Study First Received: June 26, 2012
Last Updated: March 28, 2013
Health Authority: Ukraine: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013