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

February 18, 2014 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • 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, 135-710
      • Seoul, Korea, Republic of, 134-701
    • Gang''weondo
      • Wonju-si, Gang''weondo, Korea, Republic of, 220-701
    • Korea
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm 2
Drug: Voglibose (Basen)
uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin
Experimental: Arm 1
Drug: Acarbose (Glucobay, BAYG5421)
uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glycosylated hemoglobin (HbA1c)
Time Frame: Change from baseline to week 24, at week -2, 0, 8 and 24
Change from baseline to week 24, at week -2, 0, 8 and 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Self monitoring blood glucose concentration
Time Frame: 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)
6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)
Fasting blood glucose concentration
Time Frame: At week -2, 0, 4, 8, 16 and 24
At week -2, 0, 4, 8, 16 and 24
Blood concentration of triglyceride
Time Frame: At week -2 and 24
At week -2 and 24
Blood concentration of low density lipoprotein
Time Frame: At week -2 and 24
At week -2 and 24
Blood concentration of total cholesterol
Time Frame: At week -2 and 24
At week -2 and 24
Blood concentration of high density lipoprotein
Time Frame: At week -2 and 24
At week -2 and 24
Blood concentration of apolipoprotein A-1
Time Frame: At week -2 and 24
At week -2 and 24
Blood concentration of apolipoprotein B
Time Frame: At week -2 and 24
At week -2 and 24
Blood concentration of Glucagon-like peptide-1 (GLP-1)
Time Frame: At week -0 and 24
At week -0 and 24
Body weight, Body Mass Index(BMI)
Time Frame: At week -2, 0, 4, 8, 16 and 24
At week -2, 0, 4, 8, 16 and 24
High Sensitivity C-reactive protein (hs-CRP)
Time Frame: At week -2 and 24
At week -2 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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