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

Diabetes Mellitus, Type 2 Clinical Trial

— ENERGY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928889
• Other study ID #: CDJN608ACN06
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2009
• Last updated: May 7, 2012
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Nateglinide 120 mg
Nateglinide 120 mg was supplied as tablets.
• Acarbose 50 mg
Acarbose 50 mg was supplied as tablets.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	Peiking University First Hospital	BeiJing
China	People's Liberation Army. The Military General Hospital of BeiJing	BeiJing
China	Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University	Guangzhou
China	The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University	Guangzhou
China	The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Change From Baseline in Peak Postprandial Glucose 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. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. 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)	No
Secondary	Change From Baseline in Postprandial Glucose Area Under the Curve 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. The postprandial glucose area under the curve was calculated using values from the 4 time points. 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)	No
Secondary	Change From Baseline in Total Cholesterol at the End of the Study (Week 4)	Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. Total cholesterol was assessed at each study site using the same method and same reference value.	Baseline to the end of the study (Week 4)	No
Secondary	Change From Baseline in Triglycerides at the End of the Study (Week 4)	Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. Triglycerides were assessed at each study site using the same method and same reference value.	Baseline to the end of the study (Week 4)	No
Secondary	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)	Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. LDL-C was assessed at each study site using the same method and same reference value.	Baseline to the end of the study (Week 4)	No
Secondary	Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)	Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. HDL-C was assessed at each study site using the same method and same reference value.	Baseline to the end of the study (Week 4)	No
Secondary	Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)	Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. FFA was assayed at a central laboratory.	Baseline to the end of the study (Week 4)	No
Secondary	Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)	Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. hsCRP was assayed at a central laboratory.	Baseline to the end of the study (Week 4)	No
Secondary	Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)	Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. 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. GSA was assayed at a central laboratory.	Baseline to the end of the study (Week 4)	No