Status:
UNKNOWN
A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Lotus Pharmaceutical
Conditions:
The Objectives of the Study is to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg
Plus Acarbose 50 mg Tablets) Thrice Daily Versus Acarbose 50 mg Thrice Daily Over 16 Weeks in
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin secretion deficiency and insulin action defect. In this type of subjects, fasting hyperglycemia is the result o...
Eligibility Criteria
Inclusion
- Subjects may be included in the study only if they meet all of the following criteria:
- Male or female subjects aged ≥ 20 and ≤ 80 years old;
- Subject with type 2 diabetes mellitus;
- Subject with documented HbA1c ≥ 7 % and ≤ 10 % within 3 months prior study and at screening;
- Body mass index \< 35 kg/m2;
- Subject is willing and able to comply with study procedures and sign informed consent.
Exclusion
- Subjects will be excluded from the study for any of the following reasons:
- Subject with type 1 diabetes or secondary diabetes;
- Subject with history or concurrent ketonuria or other acidosis;
- Subject with type 2 diabetes mellitus treated with high dose of sulfonylurea (gliclazide \> 320 mg, glibenclamide \> 20 mg, glimepiride \> 6 mg, and glipizide \> 20 mg) or with biguanides (metformin \> 2000 mg), or of α-glucosidase inhibitors (acarbose \> 300 mg), or with meglitinides (repaglinide \> 6 mg and nateglinide \> 360 mg), thiazolidinedione (rosiglitazone \> 4 mg, pioglitazone \> 30 mg) or with insulin;
- Subject with gastrointestinal disease that may interfere with absorption of the investigational products at discretion of investigator, including but are not limited to malabsorption syndromes and gastric ulcer;
- Subject with kidney function impairment defined as serum creatinine \> 1.5 mg/dL for male, serum creatinine \> 1.4 mg/dL for female, or liver function impairment defined as ALT \> 3 X ULN, or AST \> 3 X ULN;
- Subject with history of drug or alcohol abuse within the past 1 year;
- Subject who have been diagnosed with acute myocardial infarction or cardiac failure within 6 months preceding screening;
- Subject with hypersensitivity to acarbose and/or metformin products;
- Subject with active cancer, defined as ongoing, progressing cancer, or \< 5 years of stable disease;
- Hemoglobin values \< 10 gm/dl for females or \<11 gm/dl for males;
- Female subject of childbearing potential who:
- is lactating; or · has positive urine pregnancy test at Visit 1; or
- refuse to adopt reliable method of contraception during the study;
- Subject is contraindicated to acarbose and/or metformin treatment;
- Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
- Subject who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine,immune, neurological, or hematological disease as determined by the clinical judgment of the investigator.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01245166
Start Date
November 1 2010
End Date
December 1 2011
Last Update
November 22 2010
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705