Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Nateglinide; Acarbose
Intervention description: Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.; Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Intervention MeSH terms: Acarbose; Nateglinide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Nateglinide; Acarbose; glucose fluctuation

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)