Glucose Reduction by Early Acarbose Treatment in Basal In... | NCT00970528

Studies
Glucose Reduction by Early Acarbose Treatment in Basal Insulin

NCT00970528

Sponsor

Bayer

Status

Completed

Last Update Posted

Feb 20, 2014Estimated

Enrollment

124Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose (Glucobay, BAYG5421)
Voglibose (Basen)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2014

Last Update Posted Date

Feb 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Acarbose (Glucobay, BAYG5421)
Arm 2	Active Comparator		Drug: Voglibose (Basen)

Name	Type	Description	Arm Group Labels	Other Names
Acarbose (Glucobay, BAYG5421)	Drug	uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin	Arm 1

Measure	Description	Time Frame
Glycosylated hemoglobin (HbA1c)		Change from baseline to week 24, at week -2, 0, 8 and 24

Measure	Description	Time Frame
Self monitoring blood glucose concentration		6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)
Fasting blood glucose concentration		At week -2, 0, 4, 8, 16 and 24

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Wŏnju	Gang''weondo	220-701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24431911	Derived	Lee MY, Choi DS, Lee MK, Lee HW, Park TS, Kim DM, Chung CH, Kim DK, Kim IJ, Jang HC, Park YS, Kwon HS, Lee SH, Shin HK. Comparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study. J Korean Med Sci. 2014 Jan;29(1):90-7. doi: 10.3346/jkms.2014.29.1.90. Epub 2013 Dec 26.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D014312	Trisaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates