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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00908921
First received: May 26, 2009
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: GLIMEPIRIDE
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting Plasma Glucose (FPG) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Post Prandial Glucose (PPG) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving HbA1c <7.0 [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Enrollment: 391
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908921

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Mei Mao Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00908921     History of Changes
Other Study ID Numbers: GLIME_L_04409
Study First Received: May 26, 2009
Last Updated: August 7, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Hypoglycemic Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014