Glucose Reduction by Early Acarbose Treatment in Basal Insulin

NCT00970528 | Completed Phase 4

• 1 other identifier: 14081
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Oral Hypoglycemic Agent

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin (HbA1c)

  Change from baseline to week 24, at week -2, 0, 8 and 24

Secondary Outcomes (11)

• 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

• Blood concentration of triglyceride

  At week -2 and 24

• Blood concentration of low density lipoprotein

  At week -2 and 24

• Blood concentration of total cholesterol

  At week -2 and 24

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Acarbose (Glucobay, BAYG5421)

Arm 2

ACTIVE COMPARATOR

Drug: Voglibose (Basen)

Interventions

Acarbose (Glucobay, BAYG5421) DRUG

uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin

Arm 1

Voglibose (Basen) DRUG

uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin

Arm 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (11)

Unknown Facility

Wŏnju, Gang''weondo, 220-701, South Korea

Location

Unknown Facility

Busan, Korea, 602-714, South Korea

Location

Unknown Facility

Gyeonggi-do, Korea, 463-500, South Korea

Location

Unknown Facility

Gyeonggi-do, Korea, 471-701, South Korea

Location

Unknown Facility

Pusan, Korea, 602-739, South Korea

Location

Unknown Facility

Seoul, Korea, 150-713, South Korea

Location

Unknown Facility

Daegu, 705-717, South Korea

Location

Unknown Facility

Jeonju, 456-712, South Korea

Location

Unknown Facility

Seongbuk-gu Seoul, 136-705, South Korea

Location

Unknown Facility

Seoul, 134-701, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24431911 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose; voglibose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

KR (11)