Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
NCT ID: NCT01457911
Last Updated: 2014-05-08
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
244 participants
INTERVENTIONAL
2011-10-31
2013-02-28
Brief Summary
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* To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
* To evaluate the percentage of patients reaching HbA1c \< 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
* To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
* To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
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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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AMARYL M (Glimepiride and Metformin hydrochloride combination)
AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal
Glimepiride and Metformin hydrochloride combination (HOE490)
Pharmaceutical form:tablet Route of administration: oral
AMARYL (Glimepiride)
AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal
Glimepiride (HOE490)
Pharmaceutical form:tablet Route of administration: oral
Interventions
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Glimepiride and Metformin hydrochloride combination (HOE490)
Pharmaceutical form:tablet Route of administration: oral
Glimepiride (HOE490)
Pharmaceutical form:tablet Route of administration: oral
Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent
Exclusion Criteria
* HbA1c \< 7% or \> 10%
* Fasting plasma glucose \> 250 mg/dL (\> 13.9 mmol/L)
* Age \<18 years or Age ≥ 80 years
* Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
* Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
80 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 156001
Beijing, , China
Investigational Site Number 156016
Beijing, , China
Investigational Site Number 156003
Beijing, , China
Investigational Site Number 156018
Beijing, , China
Investigational Site Number 156002
Beijing, , China
Investigational Site Number 156019
Changchun, , China
Investigational Site Number 156017
Chengdu, , China
Investigational Site Number 156014
Guangzhou, , China
Investigational Site Number 156022
Guangzhou, , China
Investigational Site Number 156011
Hangzhou, , China
Investigational Site Number 156012
Hefei, , China
Investigational Site Number 156020
Jinan, , China
Investigational Site Number 156023
Jinan, , China
Investigational Site Number 156010
Shanghai, , China
Investigational Site Number 156006
Shanghai, , China
Investigational Site Number 156009
Shanghai, , China
Investigational Site Number 156021
Shenyang, , China
Investigational Site Number 156005
Shijiazhuang, , China
Investigational Site Number 156004
Taiyuan, , China
Investigational Site Number 156024
Tianjin, , China
Investigational Site Number 156008
Wuhan, , China
Investigational Site Number 156015
Xiamen, , China
Countries
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Other Identifiers
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U1111-1121-6792
Identifier Type: OTHER
Identifier Source: secondary_id
EFC11761
Identifier Type: -
Identifier Source: org_study_id
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