Efficacy and safety of AKE affecting decreases in postprandial blood sugar; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002617
- Lead Sponsor
- Han Kook Shin Yak Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
(1) Male and female subject aged between 20 years and 75 years
(2) Subjests with a fasting blood glucose below 125mg/dL
(3) Subjects who agree to participate in the study and sign the informed consent form
(1) Subjects with severe cerebrovascular disease(cerebral infarction, stroke etc), heart disease(angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the 6 months prior to screening.
? In the case of clinically stable subjects, the test may be conducted at the discretion of professor.
(2) Subjects who taking insulin treatments, hypoglycemic agents within the 3 months prior to screening.
(3) Subjects who have taken corticosteroids within 2 months of the start of the study
(4) An uncontrolled thyroid patient
(5) Serum creatinine = 2 times the upper limit of normal
(6) Serum AST(GOT) or ALT(GPT) = 3 times the upper limit of normal
(7) Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
(8) Subjects with CNS disorder (depressive disorder, schizophrenia, alcoholism, drug addiction)
(9) Subjects which in the opinion investigator could affect preclude evaluation of response.
(10) Women who are pregnant or lactating or planning to get pregnant
(11) Subjects who have a plan to participate in other clinical trial
(12) Participation in any clinical trial within the 3 months prior to screening
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fastng plasma glucose;2-Hour Postprandial glucose level;Oral Glucose Tolerance Test, AUC 0~2hr;HbA1c;Insulin;Connecting peptide;HOMA-Insulin resistance(IR), HOMA-ß, Quantitative insulin sensitivity check index(QUICKI)
- Secondary Outcome Measures
Name Time Method Treatment-Emergent Adverse Events, TEAEs;Clinical pathology examination;pulse, blood pressure, body weight;electrocardiography