Clinical trial NCT00928889: Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus, type 2
nateglinide
acarbose
hyperglycemia
dyslipidemias
C-reactive protein
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
Secondary outcomes:
measure: Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in Triglycerides at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
measure: Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
timeFrame: Baseline to the end of the study (Week 4)
Other outcomes:
Locations:
city: BeiJing
country: China
facility: People's Liberation Army. The Military General Hospital of BeiJing
city: BeiJing
country: China
facility: Peiking University First Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
city: Guangzhou
country: China
facility: The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
city: Guangzhou
country: China
facility: Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.