NCT01316861
Completed
Phase 3
A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
EMS1 site in 1 country79 target enrollmentSeptember 2012
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- EMS Acarbose
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- EMS
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Glycosylated hemoglobin (HbA1c)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2 Diabetic Patients Using Two Different Formulations of Acarbose 50mg.
Detailed Description
Study Design: * Multicenter * Phase III * Randomized * Double Blind * Prospective and Comparative * Experiment duration: 105 days * 5 visits * Efficacy * Adverse event
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Diagnosed with type 2 diabetes mellitus (t2dm)b
- •Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) which agree to use a medically accepted contraceptive regimen for the duration of the study.
Exclusion Criteria
- •Pregnancy or risk of pregnancy.
- •Lactation
- •Any pathology or past medical condition that can interfere with this protocol
- •Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
- •Known hypersensitivity / intolerance to acarbose or any of its excipients
Arms & Interventions
EMS Acarbose
Intervention: EMS Acarbose
Bayer Acarbose
Intervention: Bayer Acarbose
Outcomes
Primary Outcomes
Glycosylated hemoglobin (HbA1c)
Time Frame: Change from baseline to day 98
Secondary Outcomes
- Safety will be evaluated by the Adverse events occurence(Day 105)
- Decrease in mean Fasting Plasma Glucose (FPG)(Change from baseline to day 14, 28, 42, 70 and 98)
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 4
Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)Diabetes MellitusImpaired Glucose ToleranceCoronary Artery DiseaseNCT00858676Aichi Gakuin University150
Completed
Phase 2
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT00422487CymaBay Therapeutics, Inc.60
Completed
Phase 2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT00605475Novartis231
Completed
Phase 4
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM PatientsType 2 Diabetes MellitusNCT01490918The Catholic University of Korea165
Completed
Phase 1
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)DiabetesNCT01240980Bristol-Myers Squibb104