Glucose Reduction by Early Acarbose Treatment in Basal Insulin

Diabetes Mellitus, Type 2 Clinical Trial

— GREAN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970528
• Other study ID #: 14081
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2009
• Last updated: February 18, 2014
• Start date: November 2009
• Est. completion date: March 2012

Study information

• Verified date: February 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Acarbose (Glucobay, BAYG5421)
uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin
• Voglibose (Basen)
uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin (HbA1c)		Change from baseline to week 24, at week -2, 0, 8 and 24	No
Secondary	Self monitoring blood glucose concentration		6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)	No
Secondary	Fasting blood glucose concentration		At week -2, 0, 4, 8, 16 and 24	No
Secondary	Blood concentration of triglyceride		At week -2 and 24	No
Secondary	Blood concentration of low density lipoprotein		At week -2 and 24	No
Secondary	Blood concentration of total cholesterol		At week -2 and 24	No
Secondary	Blood concentration of high density lipoprotein		At week -2 and 24	No
Secondary	Blood concentration of apolipoprotein A-1		At week -2 and 24	No
Secondary	Blood concentration of apolipoprotein B		At week -2 and 24	No
Secondary	Blood concentration of Glucagon-like peptide-1 (GLP-1)		At week -0 and 24	No
Secondary	Body weight, Body Mass Index(BMI)		At week -2, 0, 4, 8, 16 and 24	No
Secondary	High Sensitivity C-reactive protein (hs-CRP)		At week -2 and 24	No

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