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Completed

NCT Number: NCT00970528

Glucose Reduction by Early Acarbose Treatment in Basal Insulin

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wŏnju, Gang''weondo, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: GREAN

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 2, 2009
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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