Glucose Reduction by Early Acarbose Treatment in Basal Insulin

NCT ID: NCT00970528

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-03-31

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Acarbose (Glucobay, BAYG5421)

Intervention Type: DRUG

uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin

Arm 2

Group Type: ACTIVE_COMPARATOR

Voglibose (Basen)

Intervention Type: DRUG

uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin

Interventions

Acarbose (Glucobay, BAYG5421)

uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin

Intervention Type: DRUG

Voglibose (Basen)

uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin

Intervention Type: DRUG

Eligibility 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 </= 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Wŏnju, Gang''weondo, South Korea

Busan, Korea, South Korea

Gyeonggi-do, Korea, South Korea

Gyeonggi-do, Korea, South Korea

Pusan, Korea, South Korea

Seoul, Korea, South Korea

Daegu, , South Korea

Jeonju, , South Korea

Seongbuk-gu Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Countries

South Korea

References

Lee MY, Choi DS, Lee MK, Lee HW, Park TS, Kim DM, Chung CH, Kim DK, Kim IJ, Jang HC, Park YS, Kwon HS, Lee SH, Shin HK. Comparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study. J Korean Med Sci. 2014 Jan;29(1):90-7. doi: 10.3346/jkms.2014.29.1.90. Epub 2013 Dec 26.

Reference Type: DERIVED

PMID: 24431911 (View on PubMed)

Other Identifiers

14081

Identifier Type: -

Identifier Source: org_study_id