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

September 1, 2009
February 18, 2014
November 2009
March 2012   (final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: Change from baseline to week 24, at week -2, 0, 8 and 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00970528 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Self monitoring blood glucose concentration [ Time Frame: 6 points for 2days 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 ]
Not Provided
Not Provided
 
Glucose Reduction by Early Acarbose Treatment in Basal Insulin
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Acarbose (Glucobay, BAYG5421)
    uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin
  • Drug: Voglibose (Basen)
    uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin
  • Experimental: Arm 1
    Intervention: Drug: Acarbose (Glucobay, BAYG5421)
  • Active Comparator: Arm 2
    Intervention: Drug: Voglibose (Basen)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00970528
14081
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP