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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00970528
First received: September 1, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Acarbose (Glucobay, BAYG5421)
Drug: Voglibose (Basen)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: Change from baseline to week 24, at week -2, 0, 8 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self monitoring blood glucose concentration [ Time Frame: 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24) ] [ Designated as safety issue: No ]
  • Fasting blood glucose concentration [ Time Frame: At week -2, 0, 4, 8, 16 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of triglyceride [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of low density lipoprotein [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of total cholesterol [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of high density lipoprotein [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of apolipoprotein A-1 [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of apolipoprotein B [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]
  • Blood concentration of Glucagon-like peptide-1 (GLP-1) [ Time Frame: At week -0 and 24 ] [ Designated as safety issue: No ]
  • Body weight, Body Mass Index(BMI) [ Time Frame: At week -2, 0, 4, 8, 16 and 24 ] [ Designated as safety issue: No ]
  • High Sensitivity C-reactive protein (hs-CRP) [ Time Frame: At week -2 and 24 ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970528

Locations
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, 471-701
Gyeonggi-do, Korea, Korea, Republic of, 463-500
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00970528     History of Changes
Other Study ID Numbers: 14081
Study First Received: September 1, 2009
Last Updated: February 18, 2014
Health Authority: Korea: Food and Drug Administration

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
Voglibose
Glargine
Insulin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014