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

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00612144
First received: January 7, 2008
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Glimepiride/metformin fixed combination
Drug: Metformin HCl
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Adjusted mean changes in HbA1c from baseline to the last visit [ Time Frame: 12~24 weeks ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment: 192
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amaryl M group
 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 Name: Amaryl M
Active Comparator: 2
Metformin group
 Drug: 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 Name: Diabex

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612144

Locations
Korea, Republic of
Handok Pharmaceuticals, Co., LTD
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Dong Seob CHOI Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Moon-Hwa Park, Head of Medical Affairs, Medical Affairs
ClinicalTrials.gov Identifier: NCT00612144     History of Changes
Other Study ID Numbers: GLIME_L_02861
Study First Received: January 7, 2008
Last Updated: March 26, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
Type 2 DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013