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

January 7, 2008
March 26, 2013
December 2007
May 2009   (final data collection date for primary outcome measure)
Adjusted mean changes in HbA1c from baseline to the last visit [ Time Frame: 12~24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612144 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
  • Experimental: 1
    Amaryl M group
    Intervention: Drug: Glimepiride/metformin fixed combination
  • Active Comparator: 2
    Metformin group
    Intervention: Drug: Metformin HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00612144
GLIME_L_02861
No
Moon-Hwa Park, Head of Medical Affairs, Medical Affairs
Handok Pharmaceuticals Co., Ltd.
Not Provided
Principal Investigator: Dong Seob CHOI Korea University Anam Hospital
Handok Pharmaceuticals Co., Ltd.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP