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OpenTrials
Completed

NCT Number: NCT00928889

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese PLA General Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nateglinide 120 mg

Drug

Nateglinide 120 mg was supplied as tablets.

Other names: Starlix

Acarbose 50 mg

Drug

Acarbose 50 mg was supplied as tablets.

Other names: Glucobay

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

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

    Time frame: Baseline to 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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

  8. 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)

    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.

  9. 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)

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ENERGY

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 26, 2009
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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