Clinical trial NCT01030952: Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Nateglinide
Acarbose
glucose fluctuation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion criteria

1. Patients must give written informed consent before any assessment is performed.
2. Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
3. 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.
4. Age in the range of 18-75 years inclusive.
5. HbA1c in the range of \> 6.5 to ≤9.0% at Visit 1.

Exclusion criteria

1. 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).
2. With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
3. A history of,

   1. type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
   2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
   3. Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
   4. percutaneous coronary intervention within the past 3 months.
   5. any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
4. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
6. Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)

Primary outcomes:
measure: Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
timeFrame: 3 weeks (end of study) minus baseline
Secondary outcomes:
measure: Change in Incremental Glucose Peak (IGP) From Baseline
timeFrame: baseline, 3 weeks (end of study)
measure: Change in Mean Blood Glucose (MBG)
timeFrame: baseline and at 3 weeks (end of study)
measure: Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.
timeFrame: baseline, 3 weeks (end of study)
measure: Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)
timeFrame: baseline, 3 weeks (end of study)
measure: Changes in 24 Hour Glucose Area Under Curve (AUCpp)
timeFrame: baseline, end of study (3 weeks)
measure: Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment
timeFrame: baseline, 3 weeks (end of study)
measure: Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline
timeFrame: baseline, 3 weeks (end of study)
measure: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: baseline, 3 weeks (end of study)
measure: Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point
timeFrame: baseline, 3 weeks (end of study)
measure: Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint
timeFrame: baseline, 3 weeks (end of study)
measure: Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study
timeFrame: baseline, 3 weeks (end of study)
measure: Change in Mean Amplitude of Glycaemic Excursion (MAGE)
timeFrame: baseline, 3 weeks (end of study)
measure: The Percent of 24 Hour Hypoglycemic Measurements
timeFrame: baseline, 3 weeks (end of study)
measure: Change in Percent of 24 Hour Hyperglycemic Measurements
timeFrame: baseline, 3 weeks (end of study)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, 3 East Qingchun Road
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, 389 Xinchun Road
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital, 600 Xuanshan Road
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Zhou J, Deng Z, Lu J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Differential therapeutic effects of nateglinide and acarbose on fasting and postprandial lipid profiles: a randomized trial. Diabetes Technol Ther. 2015 Apr;17(4):229-34. doi: 10.1089/dia.2014.0299.
citation: Zhou J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Nateglinide and acarbose are comparably effective reducers of postprandial glycemic excursions in chinese antihyperglycemic agent-naive subjects with type 2 diabetes. Diabetes Technol Ther. 2013 Jun;15(6):481-8. doi: 10.1089/dia.2013.0046. Epub 2013 Apr 30.