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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00928889
First received: June 25, 2009
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Nateglinide 120 mg
Drug: Acarbose 50 mg
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Total Cholesterol at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Triglycerides at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4) [ Time Frame: Baseline to the end of the study (Week 4) ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nateglinide 120 mg
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
Drug: Nateglinide 120 mg
Nateglinide 120 mg was supplied as tablets.
Other Name: Starlix
Active Comparator: Acarbose 50 mg
Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
Drug: Acarbose 50 mg
Acarbose 50 mg was supplied as tablets.
Other Name: Glucobay

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928889

Locations
China
Chinese PLA General Hospital
Beijing, China, 100853
Peiking University First Hospital
BeiJing, China, 100034
People's Liberation Army. The Military General Hospital of BeiJing
BeiJing, China, 100020
Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University
Guangzhou, China, 510515
The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
Guangzhou, China, 510080
The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
Guangzhou, China, 510120
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00928889     History of Changes
Other Study ID Numbers: CDJN608ACN06
Study First Received: June 25, 2009
Results First Received: June 13, 2011
Last Updated: May 7, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
diabetes mellitus, type 2
nateglinide
acarbose
hyperglycemia
dyslipidemias
C-reactive protein

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Acarbose
Nateglinide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014