Efficacy and safety of Yukmijihwang-tang added to insulin-metformin therapy in patients with type 2 diabetes -a pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001402

Enrollment

Registered

2015-03-04

Start date

2015-02-09

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Type 2 diabetes mellitus who have inadequeate glycemic control following treatment with insulin and metformin for more than three months will be included in the study. After completing the scre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Hb A1c, fructosamine, fasting glucose	—

Secondary

Measure	Time frame
HOMA-IR, HOMA-b, c-peptide, insulin, lipid profiles, body mass index, adipokines	—

Countries

Korea, Republic of

Contacts

Public Contacteunyoung Ko

Daegu Catholic Univercity Medical Center

keylgh0905@naver.com+82-53-650-4098

Outcome results