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Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Nateglinide 120 mg (Drug); Acarbose 50 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.

Clinical Details

Official title: A Multi-center, Open-label, Randomized, Active-control, Parallel-group Designed Study to Compare Effects of Nateglinide and Acarbose on Postprandial Status in Chinese Drug-naive Type 2 Diabetes Mellitus Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)

Secondary outcome:

Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)

Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)

Change From Baseline in Total Cholesterol at the End of the Study (Week 4)

Change From Baseline in Triglycerides at the End of the Study (Week 4)

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)

Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)

Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)

Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)

Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Newly diagnosed type 2 diabetes mellitus patients

- HbA1c > 6. 5 and < 9. 0%

- Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet

control Exclusion Criteria:

- History of acute metabolic complications in the past 3 months or of severe diabetic

complications or severe infections or active substance abuse

- Liver disease

- Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid

treatment within past 4 weeks Other protocol-defined inclusion/exclusion criteria applied to the study.

Locations and Contacts

Chinese PLA General Hospital, Beijing 100853, China

Peiking University First Hospital, BeiJing 100034, China

People's Liberation Army. The Military General Hospital of BeiJing, BeiJing 100020, China

Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University, Guangzhou 510515, China

The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University, Guangzhou 510080, China

The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University, Guangzhou 510120, China

Additional Information

Related publications:

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.

Starting date: July 2009
Last updated: May 7, 2012

Page last updated: August 23, 2015

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