Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes
NCT ID: NCT01630369
Last Updated: 2014-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
552 participants
INTERVENTIONAL
2012-02-29
2013-05-31
Brief Summary
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\- 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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
insulin human (HR1799)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Interventions
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insulin human (HR1799)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Kyiv, , Ukraine
Countries
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Other Identifiers
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U1111-1128-8605
Identifier Type: OTHER
Identifier Source: secondary_id
HUBIN_L_05574
Identifier Type: -
Identifier Source: org_study_id
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