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Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM) (GREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00908921
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: GLIMEPIRIDE Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
Study Start Date : April 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride

Arm Intervention/treatment
Experimental: 1

The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg.

At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg.

Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion.

Drug: GLIMEPIRIDE
Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)




Primary Outcome Measures :
  1. Change in glycosylated hemoglobin (HbA1c) rate [ Time Frame: week 16 ]

Secondary Outcome Measures :
  1. Fasting Plasma Glucose (FPG) rate [ Time Frame: week 16 ]
  2. Post Prandial Glucose (PPG) rate [ Time Frame: week 16 ]
  3. Percentage of patients achieving HbA1c <7.0 [ Time Frame: week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed <6 months and who had not taken oral antidiabetic medication or insulin for >3months.
  • HbA1C more than 7.5 and less than 11.

Exclusion Criteria:

  • Fasting plasma glucose of >13.5mmol/L
  • Type 1 Diabetes Mellitus (T1DM)
  • Patient with acute illness hospitalized in last 2 months
  • Patient with active liver disease, impaired renal or hepatic functions
  • Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
  • Pregnant and lactating women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908921


Locations
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China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Mei Mao Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00908921    
Other Study ID Numbers: GLIME_L_04409
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors