check_circleStudy Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

14081

ClinicalTrials.gov Identifier:

NCT00970528

EudraCT Number:

Not Available

EU CT Number:

Not Available
Glucose Reduction by Early Acarbose treatment in basal Insulin

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 79 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
124
Trial Dates
November 2009 - March 2012
Phase
Phase 4
Could I Receive a placebo
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Korea University Anam HospitalSeongbuk-gu Seoul, 136-705, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Chonbuk National University HospitalJeonju-si, 456-712, Korea, Republic Of
Completed
Kangdong Sacred Heart HospitalSeoul, 134-701, Korea, Republic Of
Completed
Yeungnam University Medical CenterDaegu, 705-717, Korea, Republic Of
Completed
Yonsei University Wonju Christian HospitalWonju-si, 220-701, Korea, Republic Of
Completed
Dong-A University HospitalBusan, 602-714, Korea, Republic Of
Completed
Pusan National University HospitalPusan, 602-739, Korea, Republic Of
Completed
Seoul National University Bundang HospitalGyeonggi-do, 463-500, Korea, Republic Of
Completed
Hanyang University Guri HospitalGyeonggi-do, 471-701, Korea, Republic Of
Completed
Catholic Medical CentreSeoul, 150-713, Korea, Republic Of

Primary Outcome

  • Glycosylated hemoglobin (HbA1c)
    date_rangeTime Frame:
    Change from baseline to week 24, at week -2, 0, 8 and 24
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Self monitoring blood glucose concentration
    date_rangeTime Frame:
    6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)
    enhanced_encryption
    Safety Issue:
    no
  • Fasting blood glucose concentration
    date_rangeTime Frame:
    At week -2, 0, 4, 8, 16 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of triglyceride
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of low density lipoprotein
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of total cholesterol
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of high density lipoprotein
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of apolipoprotein A-1
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of apolipoprotein B
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Blood concentration of Glucagon-like peptide-1 (GLP-1)
    date_rangeTime Frame:
    At week -0 and 24
    enhanced_encryption
    Safety Issue:
    no
  • Body weight, Body Mass Index(BMI)
    date_rangeTime Frame:
    At week -2, 0, 4, 8, 16 and 24
    enhanced_encryption
    Safety Issue:
    No
  • High Sensitivity C-reactive protein (hs-CRP)
    date_rangeTime Frame:
    At week -2 and 24
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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