Study 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

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
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

Trial summary

Enrollment Goal

124

Trial Dates

November 2009 - March 2012

Phase

Phase 4

Could I Receive a placebo

Products

Acarbose (Precose/Glucobay, BAYG5421)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Korea University Anam Hospital	Seongbuk-gu Seoul, 136-705, Korea, Republic Of
Completed	Samsung Medical Center	Seoul, 135-710, Korea, Republic Of
Completed	Chonbuk National University Hospital	Jeonju-si, 456-712, Korea, Republic Of
Completed	Kangdong Sacred Heart Hospital	Seoul, 134-701, Korea, Republic Of
Completed	Yeungnam University Medical Center	Daegu, 705-717, Korea, Republic Of
Completed	Yonsei University Wonju Christian Hospital	Wonju-si, 220-701, Korea, Republic Of
Completed	Dong-A University Hospital	Busan, 602-714, Korea, Republic Of
Completed	Pusan National University Hospital	Pusan, 602-739, Korea, Republic Of
Completed	Seoul National University Bundang Hospital	Gyeonggi-do, 463-500, Korea, Republic Of
Completed	Hanyang University Guri Hospital	Gyeonggi-do, 471-701, Korea, Republic Of
Completed	Catholic Medical Centre	Seoul, 150-713, Korea, Republic Of

Primary Outcome

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

Secondary Outcome

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

Additional Information

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