Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM | RxWiki

Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM

Overview[ - collapse ][ - ]

Purpose	The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Glimepiride/metformin fixed combination Drug: Metformin HCl
Phase	Phase 4
Sponsor	Handok Pharmaceuticals Co., Ltd.
Responsible Party	Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier	NCT00612144
First Received	January 7, 2008
Last Updated	March 26, 2013
Last verified	March 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 7, 2008
Last Updated Date	March 26, 2013
Start Date	December 2007
Estimated Primary Completion Date	May 2009
Current Primary Outcome Measures	Adjusted mean changes in HbA1c from baseline to the last visit [Time Frame: 12~24 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Adjusted mean changes in FPG from baseline to the last visit [Time Frame: 12~24 weeks] [Designated as safety issue: No] Response rate based on HbA1c and FPG levels measured at the last visit [Time Frame: 12~24 weeks] [Designated as safety issue: No] Frequency with hypoglycemic episode [Time Frame: 12~24 weeks] [Designated as safety issue: Yes] Adverse event [Time Frame: 12~24 weeks] [Designated as safety issue: Yes] Abnormal change from baseline in clinical laboratory [Time Frame: 12~24 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
Official Title	A Multicenter, Randomized, Parallel-group, Open Study to Compare the Efficacy and Safety of Early Combination Therapy With Amaryl M to Metformin Uptitration in Type 2 DM Patients Inadequately Controlled on Metformin HCL
Brief Summary	The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.
Detailed Description	Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic treatment option. Disease progression renders monotherapy less effective in controlling blood glucose over time, with approximately half of the patients requiring additional therapy by 3 years after diagnosis. As a result, the use of multiple pharmacologic agents to control blood glucose is well accepted. In combination therapy, selection of suitable drug may be individualized depending on their health conditions. However, it is advisable to select drugs having different mechanism considering their complimentary action with each other. Therefore, sulfonylureas and metformin HCL is the best combination in which "insulin deficiency" and "insulin resistance", the basic two pathophysiologies in type 2 diabetes could be targeted. The efficacy and safety of the combination with sulfonylureas and metformin HCL have been proven in numerous clinical studies as combination is more effective than monotherapy using each drug in blood glucose control. Also, new approaches are required in order to attain and maintain good glycaemic control over time and aggressive earlier introduction of combination therapy is being increasingly recommended over conventional stepwise strategies.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Glimepiride/metformin fixed combination Amaryl M 1/250mg~4/1000mg bid for 12~26 weeks Maintenance dose for 10 weeks after 2~14 weeks of dose titration Dose titration according to titration algorithm based on daily mean SMBG Other Names: Amaryl MDrug: Metformin HCl Metformin HCl 500mg~1250mg bid for 12~26 weeks Maintenance dose for 10 weeks after 2~14 weeks of dose titration Dose titration according to titration algorithm based on daily mean SMBG Other Names: Diabex
Study Arm (s)	Experimental: 1 Amaryl M group Active Comparator: 2 Metformin group

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	192
Estimated Completion Date	May 2009
Estimated Primary Completion Date	May 2009
Eligibility Criteria	Inclusion Criteria: - Ages 30 to 75 at the time of screening visit - Subjects with type 2 DM diagnosed for at least 3 months before screening - Subjects with type 2 DM treated with monotherapy of 500mg ≤ metformin ≤ 1000mg for at lest 4 weeks prior to screening - HbA1c ≥ 7.0% but ≤ 10.0% at the time of screening visit - 21 kg/m2 ≤ BMI ≤ 40 kg/m2 - A negative pregnancy test for all females of childbearing potential - Provision of signed and dated informed consent prior to any study procedures - Ability and willingness to perform SMBG and record the data on the subject's diary Exclusion Criteria: - A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening - Current therapy with anti-hyperglycemic agents (except metformin) use in the 4 weeks (8 weeks in case of thiazolidinedione) before screening - Concomitant treatment prohibited during the study period - Any oral hypoglycemic agent other than glimepiride, metformin HCl, and fixed-dose combination of glimepiride and metformin HCl - Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study - Intermittent use of systemic corticosteroids or large dose of inhaled steroids - Subjects with clinically significant renal (serum creatinine level > 1.5 mg/dL in male and > 1.4 mg/dL in female) or hepatic disease (ALT and AST > 2x ULN) - Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor; - Pregnant or lactating females - History of drug or alcohol abuse - Subjects who have a history of noncompliance with regards to follow-up medical care - Subjects with known hypersensitivity to glimepiride, metformin HCL - Night-shift workers - Treatment with any investigational product in the last 3 months before study entry - Others; subjects who have participated in this study
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT00612144
Other Study ID Numbers	GLIME_L_02861
Has Data Monitoring Committee	No
Information Provided By	Handok Pharmaceuticals Co., Ltd.
Study Sponsor	Handok Pharmaceuticals Co., Ltd.
Collaborators	Not Provided
Investigators	Principal Investigator: Dong Seob CHOI Korea University Anam Hospital
Verification Date	March 2013

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