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 - Full Text View

Sponsor:	Handok Pharmaceuticals Co., Ltd.
Information provided by:	Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00913367

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Glimepiride Insulin glargine Metformin Metformin hydrochloride

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
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 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

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
Ji Young Kim	Recruiting
Seoul, Korea, Republic of
Contact: Ji Y Kim 82-2-527-5553 JiYoung4.Kim@handok.com

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:	June 2, 2009
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 February 09, 2012