Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion

NCT01030952 | Completed Phase 4 Results

• 1 other identifier: CDJN608ACN07
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Nateglinide; Acarbose; glucose fluctuation

Outcome Measures

Primary Outcomes (1)

• Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)

  The postprandial glucose area under the curve (AUC)was calculated using values from the 3 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. 0-4 hours AUC were calculated using trapezoid methods.

  3 weeks (end of study) minus baseline

Secondary Outcomes (14)

• Change in Incremental Glucose Peak (IGP) From Baseline

  baseline, 3 weeks (end of study)

• Change in Mean Blood Glucose (MBG)

  baseline and at 3 weeks (end of study)

• Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.

  baseline, 3 weeks (end of study)

• Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)

  baseline, 3 weeks (end of study)

• Changes in 24 Hour Glucose Area Under Curve (AUCpp)

  baseline, end of study (3 weeks)

Study Arms (2)

Nateglinide

EXPERIMENTAL

Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.

Drug: Nateglinide

Acarbose

ACTIVE COMPARATOR

Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.

Drug: Acarbose

Interventions

Nateglinide DRUG

Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.

Nateglinide

Acarbose DRUG

Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.

Acarbose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Sir Run Run Shaw Hospital, 3 East Qingchun Road

Hangzhou, 310016, China

Location

Shanghai Tongji Hospital, 389 Xinchun Road

Shanghai, 200065, China

Location

Shanghai Sixth People's Hospital, 600 Xuanshan Road

Shanghai, 200233, China

Location

Related Publications (3)

• 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.

  PMID: 17376293 BACKGROUND

• 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.

  PMID: 25781235 DERIVED

• 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.

  PMID: 23631607 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nateglinide; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

+1-800-244-7668

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 19, 2012
• Results First Posted: October 19, 2012

Record last verified: 2012-09

Locations

CN (3)