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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913367
• Other study ID #: HANDOK2008.10
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2009
• Last updated: March 26, 2013
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2013
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	HeeYoung Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c from baseline to the last visit		16 weeks	No
Secondary	Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events		16 weeks	No
Secondary	Response rate based on HbA1c and FPG levels measured at the last visit		16 weeks	No
Secondary	Mean change in Lantus® dose from baseline to the last visit		16 weeks	No
Secondary	Compliance		16 weeks	No
Secondary	Frequency with hypoglycemic episode		16weeks	Yes
Secondary	Adverse events		16 weeks	Yes