Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
NCT ID: NCT01030952
Last Updated: 2012-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2009-12-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nateglinide
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
Nateglinide
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
Acarbose
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Acarbose
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Interventions
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Nateglinide
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
Acarbose
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Eligibility Criteria
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Inclusion Criteria
2. Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
3. Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
4. Age in the range of 18-75 years inclusive.
5. HbA1c in the range of \> 6.5 to ≤9.0% at Visit 1.
Exclusion Criteria
2. With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
3. A history of,
1. type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
3. Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
4. percutaneous coronary intervention within the past 3 months.
5. any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
4. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
6. Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Sir Run Run Shaw Hospital, 3 East Qingchun Road
Hangzhou, , China
Shanghai Tongji Hospital, 389 Xinchun Road
Shanghai, , China
Shanghai Sixth People's Hospital, 600 Xuanshan Road
Shanghai, , China
Countries
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References
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Gao HW, Xie C, Wang HN, Lin YJ, Hong TP. Beneficial metabolic effects of nateglinide versus acarbose in patients with newly-diagnosed type 2 diabetes. Acta Pharmacol Sin. 2007 Apr;28(4):534-9. doi: 10.1111/j.1745-7254.2007.00534.x.
Zhou J, Deng Z, Lu J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Differential therapeutic effects of nateglinide and acarbose on fasting and postprandial lipid profiles: a randomized trial. Diabetes Technol Ther. 2015 Apr;17(4):229-34. doi: 10.1089/dia.2014.0299.
Zhou J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Nateglinide and acarbose are comparably effective reducers of postprandial glycemic excursions in chinese antihyperglycemic agent-naive subjects with type 2 diabetes. Diabetes Technol Ther. 2013 Jun;15(6):481-8. doi: 10.1089/dia.2013.0046. Epub 2013 Apr 30.
Other Identifiers
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CDJN608ACN07
Identifier Type: -
Identifier Source: org_study_id