Trial Condition(s):

Diabetes Mellitus, Type 2

Glucose Reduction by Early Acarbose treatment in basal Insulin (GREAN)

Bayer Identifier:

14081 Identifier:


EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
Trial Dates
Could I receive a placebo?
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteers

Where to Participate


Korea University Anam Hospital

Seongbuk-gu Seoul, South Korea, 136-705


Samsung Medical Center

Seoul, South Korea, 135-710


Chonbuk National University Hospital

Jeonju-si, South Korea, 456-712


Kangdong Sacred Heart Hospital

Seoul, South Korea, 134-701


Yeungnam University Medical Center

Daegu, South Korea, 705-717


Yonsei University Wonju Christian Hospital

Wonju-si, South Korea, 220-701


Dong-A University Hospital

Busan, South Korea, 602-714


Pusan National University Hospital

Pusan, South Korea, 602-739


Seoul National University Bundang Hospital

Gyeonggi-do, South Korea, 463-500


Hanyang University Guri Hospital

Gyeonggi-do, South Korea, 471-701


Catholic Medical Centre

Seoul, South Korea, 150-713

Trial Design