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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

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00913367
First received: May 26, 2009
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Mean change in HbA1c from baseline to the last visit [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Response rate based on HbA1c and FPG levels measured at the last visit [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Mean change in Lantus® dose from baseline to the last visit [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Frequency with hypoglycemic episode [ Time Frame: 16weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913367

Locations
Korea, Republic of
HeeYoung Lee
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Kang S Park Eulji University Hospital
  More Information

No publications provided

Responsible Party: Moon Hwa Park / Medical Research Team Manager, Medical Research Team
ClinicalTrials.gov Identifier: NCT00913367     History of Changes
Other Study ID Numbers: HANDOK2008.10
Study First Received: May 26, 2009
Last Updated: March 26, 2013
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Metformin
 Insulin, Long-Acting
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 May 22, 2013