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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01630369
First received: June 26, 2012
Last updated: May 16, 2014
Last verified: May 2014
  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 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.

Resource links provided by NLM:


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


Enrollment: 552
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 16, 2014
Health Authority: Ukraine: Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014