Phase 4 N=160 Randomized Treatment

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00928889 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) — -1.775; -2.434 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nateglinide 120 mg (Drug); Acarbose 50 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)	-1.775; -2.434	—
SECONDARY Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)	-2.350; -3.129	—
SECONDARY Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)	-217.628; -278.447	—
SECONDARY Change From Baseline in Total Cholesterol at the End of the Study (Week 4)	0.015; -0.149; 0.010; -0.059	—
SECONDARY Change From Baseline in Triglycerides at the End of the Study (Week 4)	-0.010; -0.418; 0.026; -0.396	—
SECONDARY Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)	0.036; 0.036; -0.000; 0.044	—
SECONDARY Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)	0.020; -0.039; 0.023; 0.003	—
SECONDARY Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)	-0.048; -0.040; -0.112; -0.048; -0.224; -0.048	—
SECONDARY Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)	-0.229; 0.080; -0.227; 0.024; -0.219; 0.071	—
SECONDARY Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)	-1.2; -1.2	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00928889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.