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CompletedNCT00970528GREANUpdated Feb 20, 2014

Glucose Reduction by Early Acarbose Treatment in Basal Insulin

A Phase 4 interventional study of Acarbose (Glucobay, BAYG5421) and Voglibose (Basen) in Diabetes Mellitus, Type 2, sponsored by Bayer. Completed at 11 sites in South Korea. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2014-02-20.

Sponsored by Bayer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Oral Hypoglycemic Agent
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 124 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Acarbose (Glucobay, BAYG5421)

  • Active comparator
    Arm 2

    Drug: Voglibose (Basen)

Interventions

  • DrugAcarbose (Glucobay, BAYG5421)

    uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin

  • DrugVoglibose (Basen)

    uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin

06

What researchers measure

Primary outcomes

  1. Glycosylated hemoglobin (HbA1c)

    Time frame: Change from baseline to week 24, at week -2, 0, 8 and 24

Secondary outcomes

  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

07

Study locations

11 sites
  • Wŏnju, Gang''weondo 220-701, South Korea
  • Busan, Korea 602-714, South Korea
  • Gyeonggi-do, Korea 463-500, South Korea
  • Gyeonggi-do, Korea 471-701, South Korea
  • Pusan, Korea 602-739, South Korea
  • Seoul, Korea 150-713, South Korea
  • Daegu, 705-717, South Korea
  • Jeonju, 456-712, South Korea
  • Seongbuk-gu Seoul, 136-705, South Korea
  • Seoul, 134-701, South Korea
  • Seoul, 135-710, South Korea
08

References and documents

Publications

  • 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. PubMed 24431911 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00970528
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Sep 2, 2009
Start date
Nov 2009
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Feb 20, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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