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

Novartis

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Acarbose 50 mg; Drug: Nateglinide 120 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928889

CDJN608ACN06

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Nateglinide 120 mg

Experimental group

Description:

Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.

Treatment:

Drug: Nateglinide 120 mg

Acarbose 50 mg

Active Comparator group

Description:

Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.

Treatment:

Drug: Acarbose 50 mg