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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00970528
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : February 20, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Acarbose (Glucobay, BAYG5421) Drug: Voglibose (Basen) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Acarbose (Glucobay, BAYG5421)
uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin

Active Comparator: Arm 2 Drug: Voglibose (Basen)
uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin

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

Secondary Outcome Measures :
  1. Self monitoring blood glucose concentration [ Time Frame: 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24) ]
  2. Fasting blood glucose concentration [ Time Frame: At week -2, 0, 4, 8, 16 and 24 ]
  3. Blood concentration of triglyceride [ Time Frame: At week -2 and 24 ]
  4. Blood concentration of low density lipoprotein [ Time Frame: At week -2 and 24 ]
  5. Blood concentration of total cholesterol [ Time Frame: At week -2 and 24 ]
  6. Blood concentration of high density lipoprotein [ Time Frame: At week -2 and 24 ]
  7. Blood concentration of apolipoprotein A-1 [ Time Frame: At week -2 and 24 ]
  8. Blood concentration of apolipoprotein B [ Time Frame: At week -2 and 24 ]
  9. Blood concentration of Glucagon-like peptide-1 (GLP-1) [ Time Frame: At week -0 and 24 ]
  10. Body weight, Body Mass Index(BMI) [ Time Frame: At week -2, 0, 4, 8, 16 and 24 ]
  11. High Sensitivity C-reactive protein (hs-CRP) [ Time Frame: At week -2 and 24 ]

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00970528

Korea, Republic of
Wonju-si, Gang''weondo, Korea, Republic of, 220-701
Busan, Korea, Korea, Republic of, 602-714
Gyeonggi-do, Korea, Korea, Republic of, 463-500
Gyeonggi-do, Korea, Korea, Republic of, 471-701
Pusan, Korea, Korea, Republic of, 602-739
Seoul, Korea, Korea, Republic of, 150-713
Daegu, Korea, Republic of, 705-717
Jeonju-si, Korea, Republic of, 456-712
Seongbuk-gu Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 134-701
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT00970528     History of Changes
Other Study ID Numbers: 14081
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Oral Hypoglycemic Agent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action