Glucose Reduction by Early Acarbose Treatment in Basal Insulin (GREAN)

Bayer

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Acarbose (Glucobay, BAYG5421)

Drug: Voglibose (Basen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970528

14081

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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