Glucose Reduction by Early Acarbose Treatment in Basal Insulin

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00970528
• Date of registration: 01/09/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Glucose Reduction by Early Acarbose Treatment in Basal Insulin GREAN
• Scientific title: A Randomized, Parallel Group, Open-Label, Active-Controlled Study Comparing Acarbose With Voglibose in Patients Who Are Inadequately Controlled With Insulin Glargine Alone or in Combination With Metformin Based on Glycemic Control
• Date of first enrolment: November 2009
• Target sample size: 124
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00970528
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Voglibose (Basen)

Drug: Acarbose (Glucobay, BAYG5421)

Primary Outcome(s)

Glycosylated hemoglobin (HbA1c) [Time Frame: Change from baseline to week 24, at week -2, 0, 8 and 24]

Secondary Outcome(s)

Blood concentration of apolipoprotein B [Time Frame: At week -2 and 24]

Fasting blood glucose concentration [Time Frame: At week -2, 0, 4, 8, 16 and 24]

Blood concentration of high density lipoprotein [Time Frame: At week -2 and 24]

Blood concentration of total cholesterol [Time Frame: At week -2 and 24]

Blood concentration of Glucagon-like peptide-1 (GLP-1) [Time Frame: At week -0 and 24]

Blood concentration of low density lipoprotein [Time Frame: At week -2 and 24]

Blood concentration of apolipoprotein A-1 [Time Frame: At week -2 and 24]

Self monitoring blood glucose concentration [Time Frame: 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)]

Blood concentration of triglyceride [Time Frame: At week -2 and 24]

High Sensitivity C-reactive protein (hs-CRP) [Time Frame: At week -2 and 24]

Body weight, Body Mass Index(BMI) [Time Frame: At week -2, 0, 4, 8, 16 and 24]

Secondary ID(s)

14081

Source(s) of Monetary Support

Please refer to primary and secondary sponsors