Efficacy and safety of Yukmijihwang-tang added to insulin-metformin therapy in patients with type 2 diabetes -a pilot study
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001402
- Lead Sponsor
- Daegu Catholic Univercity Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 14
Patients are eligible to be included in the study only if they meet all of the following criteria;
? Subject who is more than18 years of age and younger than 80 years of age has been diagnosed with type 2 diabetes mellitus.
? Subject who has been treated with metformin and insulin for at least 3 months has a Hb A1c value more than 7.5%, and should be required more intense medications, based on the investigator's judgement.
? Subject agrees to participate in this study and writes Informed consent.
Paitent will be excluded from the study if they meet any of the following criteria;
? Subject has developed weight loss due to poorly controlled glucose for at least 3 months.
? Subject has taking the any drugs including weight loss medication which have the potential confounding effect in the study.
? Subject has a history of imparied thyroid function.(Exceptionally, if the patient is left with the normal functioning thyroid for at least 6 months, he/she can be included)
? Subject is participating in another clinical study.
? Subject has a history of an active malignancy or serious conditions such as hepatic or renal disease.
? Subject is the female of childbearing potential who are pregnant,breast-feeding, or not using adequate contraceptive methods
? Subject has episodes of nause, vomiting, or acute gastrointestinal symptom within the 2 weeks before
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hb A1c, fructosamine, fasting glucose
- Secondary Outcome Measures
Name Time Method HOMA-IR, HOMA-b, c-peptide, insulin, lipid profiles, body mass index, adipokines