Glucose Reduction by Early Acarbose Treatment in Basal Insulin

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Acarbose; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin; Voglibose

Criteria

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 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