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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00612144
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : March 28, 2013
Information provided by:
Handok Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Glimepiride/metformin fixed combination Drug: Metformin HCl Phase 4

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  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Adjusted mean changes in HbA1c from baseline to the last visit [ Time Frame: 12~24 weeks ]

Secondary Outcome Measures :
  1. Adjusted mean changes in FPG from baseline to the last visit [ Time Frame: 12~24 weeks ]
  2. Response rate based on HbA1c and FPG levels measured at the last visit [ Time Frame: 12~24 weeks ]
  3. Frequency with hypoglycemic episode [ Time Frame: 12~24 weeks ]
  4. Adverse event [ Time Frame: 12~24 weeks ]
  5. Abnormal change from baseline in clinical laboratory [ Time Frame: 12~24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612144

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Moon-Hwa Park, Head of Medical Affairs, Medical Affairs Identifier: NCT00612144     History of Changes
Other Study ID Numbers: GLIME_L_02861
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

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
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors