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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

November 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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