Trial Condition(s):
Glucose Reduction by Early Acarbose treatment in basal Insulin (GREAN)
14081
Not Available
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The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately controlled with insulin glargine alone or in combination with metformin.
- Aged 18-79 years - Type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin -- Diagnosed of type 2 diabetes for at least 6 months prior to screening -- Treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening -- HbA1C > 7.0 and </= 10.0% at screening
- Type 1 diabetes patients - Myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months - Clinical evidence of active liver disease, or serum ALT or AST 3 times the upper limit of the normal (ULN) range - Serum creatinine >/= 1.5 mg/dl for males, >/= 1.4 mg/dl for females - Active proliferative diabetic retinopathy - Any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry - Gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias) - Galactose intolerance - Pregnancy - Delivery, abortion, or lactation within less than three cycles before the start of treatment - No use of contraceptive in childbearing aged. Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration. - Hypersensitivity to the active substances or any of gradient of the study drug ingredients - Treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry - Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Locations | |
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Locations Korea University Anam Hospital Seongbuk-gu Seoul, South Korea, 136-705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chonbuk National University Hospital Jeonju-si, South Korea, 456-712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kangdong Sacred Heart Hospital Seoul, South Korea, 134-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yeungnam University Medical Center Daegu, South Korea, 705-717 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yonsei University Wonju Christian Hospital Wonju-si, South Korea, 220-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dong-A University Hospital Busan, South Korea, 602-714 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pusan National University Hospital Pusan, South Korea, 602-739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Bundang Hospital Gyeonggi-do, South Korea, 463-500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hanyang University Guri Hospital Gyeonggi-do, South Korea, 471-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catholic Medical Centre Seoul, South Korea, 150-713 | Contact Us: E-mail: [email protected] Phone: Not Available |
A Randomized, Parallel Group, Open-Label, Active-Controlled Study Comparing Acarbose With Voglibose in Patients who are Inadequately Controlled With Insulin Glargine Alone or in Combination With Metformin Based on Glycemic Control
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2