Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus

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.
 
ClinicalTrials.gov Identifier: NCT00913367
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2013
Sponsor:
Information provided by:
Handok Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: glimepiride + insulin glargine (Amaryl + Lantus) Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus) Phase 4

Detailed Description:

There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM. Among them, sulfonylurea and metformin are well-established first-line OADs. However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs. Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure. But, it still remains unclear which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

so, this study we will be able to verify which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open, Randomized, Parallel-group, 2 Arm Study to Compare the Efficacy and Safety of Amaryl®M 1/500mg Twice Daily Versus Amaryl® 4mg Both in Combination With Lantus® Once-daily Regimen in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Amaryl group Drug: glimepiride + insulin glargine (Amaryl + Lantus)
  • Amaryl® 4 mg at breakfast + Lantus® at dinner
  • The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast
Other Names:
  • Amaryl
  • Lantus injection solostar
Experimental: Amaryl M group Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)
  • Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner
  • The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast
Other Names:
  • Amaryl M
  • Lantus injection solostar


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean change in HbA1c from baseline to the last visit [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events [ Time Frame: 16 weeks ]
  2. Response rate based on HbA1c and FPG levels measured at the last visit [ Time Frame: 16 weeks ]
  3. Mean change in Lantus® dose from baseline to the last visit [ Time Frame: 16 weeks ]
  4. Compliance [ Time Frame: 16 weeks ]
  5. Frequency with hypoglycemic episode [ Time Frame: 16weeks ]
  6. Adverse events [ Time Frame: 16 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 20 years old with type 2 DM
  • Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.
  • 7%<HbA1c<11 % at screening
  • 21 kg/m2 ≤ BMI ≤ 30 kg/m2
  • Patents who need insulin add-on therapy based on investigator's discretion
  • Patients who would give the informed consent
  • Patients who can perform SMBG and record the data on the patient's diary

Exclusion Criteria:

  • History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
  • Pregnant or lactating females
  • History of drug or alcohol abuse
  • Patients with known hypersensitivity to glimepiride, metformin HCL or insulin
  • Night-shift workers
  • Patients who are under insulin therapy at screening
  • Treatment with any investigational products in the last 3 months before screening
  • Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision
  • Patients with serum creatinine level > 1.5 mg/dl in male and > 1.4 mg/dl in female
  • Patients with ALT or AST > 3x ULN
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00913367


Locations
Layout table for location information
Korea, Republic of
HeeYoung Lee
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Inc.
Investigators
Layout table for investigator information
Principal Investigator: Kang S Park Eulji University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Moon Hwa Park / Medical Research Team Manager, Medical Research Team
ClinicalTrials.gov Identifier: NCT00913367    
Other Study ID Numbers: HANDOK2008.10
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013
Keywords provided by Handok Inc.:
Type 2 Diabetes Mellitus
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
 Insulin Glargine
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors