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

NCT00928889 | Completed Phase 4 Results

• 1 other identifier: CDJN608ACN06
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, type 2; nateglinide; acarbose; hyperglycemia; dyslipidemias; C-reactive protein

Outcome Measures

Primary Outcomes (1)

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

  Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.

  Baseline to the end of the study (Week 4)

Secondary Outcomes (9)

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

  Baseline to 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)

  Baseline to the end of the study (Week 4)

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

  Baseline to the end of the study (Week 4)

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

  Baseline to 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)

  Baseline to the end of the study (Week 4)

Study Arms (2)

Nateglinide 120 mg

EXPERIMENTAL

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

Drug: Nateglinide 120 mg

Acarbose 50 mg

ACTIVE COMPARATOR

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

Drug: Acarbose 50 mg

Interventions

Nateglinide 120 mg DRUG

Nateglinide 120 mg was supplied as tablets.

Also known as: Starlix

Nateglinide 120 mg

Acarbose 50 mg DRUG

Acarbose 50 mg was supplied as tablets.

Also known as: Glucobay

Acarbose 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

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

Beijing, 100020, China

Location

Peiking University First Hospital

Beijing, 100034, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

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

Guangzhou, 510080, China

Location

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

Guangzhou, 510120, China

Location

Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University

Guangzhou, 510515, China

Location

Related Publications (1)

• 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.

  PMID: 17376293 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Dyslipidemias

Interventions

Nateglinide; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 10, 2012
• Results First Posted: July 7, 2011

Record last verified: 2012-05

Locations

CN (6)