Phase 4
Completed N=103
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Source: ClinicalTrials.gov NCT01030952 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) — -9.20; -9.92 millimoles hours per litre (mmol*hr/L)
Summary
A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) |
-9.20; -9.92 | — |
| SECONDARY Change in Incremental Glucose Peak (IGP) From Baseline |
-2.72; -1.89 | — |
| SECONDARY Change in Mean Blood Glucose (MBG) |
-1.16; -0.78 | — |
| SECONDARY Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. |
-0.48; -0.63 | — |
| SECONDARY Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) |
-0.06; -0.21 | — |
| SECONDARY Changes in 24 Hour Glucose Area Under Curve (AUCpp) |
-1.16; -0.78 | — |
| SECONDARY Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment |
-2.22; -1.74 | — |
| SECONDARY Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline |
0.32; -0.21; 13.87; -6.64; 15.03; -16.24 | — |
| SECONDARY Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |
-0.04; 0.064; -0.06; 0.09; -0.04; 0.13 | — |
| SECONDARY Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point |
-0.03; -0.09; -0.06; 0.56; -0.01; 0.03 | — |
| SECONDARY Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint |
-0.19; -0.48; -0.23; -0.39; -0.19; -0.47 | — |
| SECONDARY Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study |
0.20; -0.02; 0.02; 0.01; 0.03; 0.00 | — |
| SECONDARY Change in Mean Amplitude of Glycaemic Excursion (MAGE) |
5.27; 5.03 | — |
| SECONDARY The Percent of 24 Hour Hypoglycemic Measurements |
0.82; -0.57 | — |
| SECONDARY Change in Percent of 24 Hour Hyperglycemic Measurements |
-50.83; -33.82 | — |
Eligibility Criteria
Inclusion criteria
- Patients must give written informed consent before any assessment is performed.
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
- Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
- Age in the range of 18-75 years inclusive.
- HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.
Exclusion criteria
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL).
- With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
- A history of,
- type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
- percutaneous coronary intervention within the past 3 months.
- any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
- Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
- Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
Data sourced from ClinicalTrials.gov (NCT01030952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.