Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 Weeks in Type 2 Diabetes Patients With Insulin Therapy
NCT ID: NCT01353469
Last Updated: 2013-02-27
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
PHASE3
485 participants
INTERVENTIONAL
2011-05-31
2012-11-30
Brief Summary
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To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.
Secondary Objectives:
* To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus on fasting plasma glucose (FPG)
* To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insuman Comb 25
Insuman Comb 25 will be self-injected subcutaneously twice daily 30-45 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline.
Insulin human/Insuman Comb 25 (HR1799)
Pharmaceutical form:Suspension
Route of administration: Subcutaneous
Novolin® 30R
Novolin® 30R will be self-injected subcutaneously twice daily within 30 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline and the package insert of Novolin® 30R
Insulin human/Novolin® 30R
Pharmaceutical form:Suspension
Route of administration: Subcutaneous
Interventions
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Insulin human/Insuman Comb 25 (HR1799)
Pharmaceutical form:Suspension
Route of administration: Subcutaneous
Insulin human/Novolin® 30R
Pharmaceutical form:Suspension
Route of administration: Subcutaneous
Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent
Exclusion Criteria
* No self-monitoring of blood glucose within 3 months prior to screening visit
* Premix insulin treatment for less than 3 months. Insulins other than premix insulin treatment within 3 months prior to screening visit
* In case of treatment with OAD, treatment with a stable OAD dose and regimen for less than 3 months prior to screening visit
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
75 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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Investigational Site Number 156024
Beijing, , China
Investigational Site Number 156010
Beijing, , China
Investigational Site Number 156001
Beijing, , China
Investigational Site Number 156033
Changchun, , China
Investigational Site Number 156017
Changchun, , China
Investigational Site Number 156005
Changsha, , China
Investigational Site Number 156021
Chengdu, , China
Investigational Site Number 156006
Chongqing, , China
Investigational Site Number 156032
Hangzhou, , China
Investigational Site Number 156007
Harbin, , China
Investigational Site Number 156020
Hefei, , China
Investigational Site Number 156016
Nanjing, , China
Investigational Site Number 156018
Nanjing, , China
Investigational Site Number 156002
Shanghai, , China
Investigational Site Number 156023
Shanghai, , China
Investigational Site Number 156031
Shanghai, , China
Investigational Site Number 156004
Shanghai, , China
Investigational Site Number 156027
Shenyang, , China
Investigational Site Number 156029
Suzhou, , China
Investigational Site Number 156025
Tianjin, , China
Investigational Site Number 156003
Wuhan, , China
Investigational Site Number 156008
Xi'an, , China
Investigational Site Number 156009
Xi'an, , China
Countries
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Other Identifiers
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U1111-1120-0701
Identifier Type: OTHER
Identifier Source: secondary_id
EFC12059
Identifier Type: -
Identifier Source: org_study_id
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