Trial Condition(s):

Diabetes Mellitus, Type 2

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

Bayer Identifier:

14081

ClinicalTrials.gov Identifier:

NCT00970528

EudraCT 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
124
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Korea University Anam Hospital

Seongbuk-gu Seoul, South Korea, 136-705

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Chonbuk National University Hospital

Jeonju-si, South Korea, 456-712

Status
Completed
 
Locations

Kangdong Sacred Heart Hospital

Seoul, South Korea, 134-701

Status
Completed
 
Locations

Yeungnam University Medical Center

Daegu, South Korea, 705-717

Status
Completed
 
Locations

Yonsei University Wonju Christian Hospital

Wonju-si, South Korea, 220-701

Status
Completed
 
Locations

Dong-A University Hospital

Busan, South Korea, 602-714

Status
Completed
 
Locations

Pusan National University Hospital

Pusan, South Korea, 602-739

Status
Completed
 
Locations

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea, 463-500

Status
Completed
 
Locations

Hanyang University Guri Hospital

Gyeonggi-do, South Korea, 471-701

Status
Completed
 
Locations

Catholic Medical Centre

Seoul, South Korea, 150-713

Status
Completed
 

Trial Design