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Completed

NCT Number: NCT00908921

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glimepiride

Drug

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

Primary outcomes

  1. Change in glycosylated hemoglobin (HbA1c) rate

    Time frame: week 16

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: GREAT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 27, 2009
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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