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Diabetes Mellitus, Type 2Phase 4GREANNCT00970528

Glucose Reduction by Early Acarbose Treatment in Basal Insulin

A Phase 4 study testing Acarbose (Glucobay, BAYG5421) and Voglibose (Basen) in people with Diabetes Mellitus, Type 2, run by Bayer at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Acarbose (Glucobay, BAYG5421) and Voglibose (Basen)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
11 sitesSouth Korea
Study dates
Nov 2009to Mar 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Study site

    Busan, Korea, 602-714

  • Study site

    Daegu, 705-717

  • Study site

    Gyeonggi-do, Korea, 463-500

  • Study site

    Gyeonggi-do, Korea, 471-701

  • Study site

    Jeonju, 456-712

  • Study site

    Pusan, Korea, 602-739

  • Study site

    Seongbuk-gu Seoul, 136-705

  • Study site

    Seoul, Korea, 150-713

  • Study site

    Seoul, 134-701

  • Study site

    Seoul, 135-710

  • Study site

    Wŏnju, Gang''weondo, 220-701

Other trials in South Korea

About this study

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

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.

Being tested
Acarbose (Glucobay, BAYG5421), Voglibose (Basen)
Keywords
Oral Hypoglycemic Agent
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acarbose (Glucobay, BAYG5421)Drug

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

  • Voglibose (Basen)Drug

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

Study groups in NCT00970528
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Acarbose (Glucobay, BAYG5421)
Arm 2Active comparatorNot described
Receives: Drug: Voglibose (Basen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycosylated hemoglobin (HbA1c)

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

Secondary outcomes (11)

  1. Self monitoring blood glucose concentration

    Measured: 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)

  2. Fasting blood glucose concentration

    Measured: At week -2, 0, 4, 8, 16 and 24

  3. Blood concentration of triglyceride

    Measured: At week -2 and 24

  4. Blood concentration of low density lipoprotein

    Measured: At week -2 and 24

  5. Blood concentration of total cholesterol

    Measured: At week -2 and 24

  6. Blood concentration of high density lipoprotein

    Measured: At week -2 and 24

  7. Blood concentration of apolipoprotein A-1

    Measured: At week -2 and 24

  8. Blood concentration of apolipoprotein B

    Measured: At week -2 and 24

  9. Blood concentration of Glucagon-like peptide-1 (GLP-1)

    Measured: At week -0 and 24

  10. Body weight, Body Mass Index(BMI)

    Measured: At week -2, 0, 4, 8, 16 and 24

  11. High Sensitivity C-reactive protein (hs-CRP)

    Measured: At week -2 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00970528
Sponsor's protocol ID
14081
Acronym
GREAN
Status last verified
Feb 2014
First submitted
1 Sep 2009
Last updated
20 Feb 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acarbose (Glucobay, BAYG5421) and Voglibose (Basen) in people with Diabetes Mellitus, Type 2, run by Bayer at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated hemoglobin (HbA1c) (time frame: Change from baseline to week 24, at week -2, 0, 8 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00970528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.

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