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OpenTrials
Completed

NCT Number: NCT01630369

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

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)

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Kyiv, Ukraine

About this study

6 months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin human (HR1799)

Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Other names: Insuman Basal / Insuman Comb / Insuman Rapid

Primary outcomes

  1. Decrease of Hb A1c ≥ 1%

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Percentage of patients with Hb A1c < 7.5%

    Time frame: 6 months

  2. Rate of hypoglycaemias (symptomatic, severe)

    Time frame: 6 months

  3. Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)

    Time frame: 6 months

  4. Change in FPG

    Time frame: Baseline 6 months

  5. Number of patients with adverse events

    Time frame: 6 months

  6. Assessment of efficacy of education courses in Diabetes Schools

    Time frame: Baseline, 6 months

    Percentage of correct answers after second test compare to the testing of the initial level

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: SPIRIT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2012
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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