Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 16-Week Controlled, Double Blind, Double Dummy, Randomized, Two Arm Parallel-Group Study to Compare the Efficacy and Safety of Amaryl M 1/250 mg b.i.d vs. Amaryl M SR 2/500 mg od. in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437554
• Other study ID #: GLIME_L_01019
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2007
• Last updated: November 28, 2007
• Start date: August 2006
• Est. completion date: July 2007

Study information

• Verified date: November 2007
• 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

Primary:

To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM)

Secondary: To compare the following parameters in two treatment arm

• Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)

• Response rates in terms of HbA1c, FPG

• Patient compliance

Safety:

• episodes of hypoglycemia

• adverse events

• laboratory values including hematology blood chemistry and urinalysis

• vital sign and physical examination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects with type 2 DM diagnosed for at least 3 months but no longer than 10 years before screening;

• - BMI = 40 kg/m²;

• A negative pregnancy test for all females of childbearing potential

Exclusion Criteria:

• A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;

• Current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;

• Concomitant treatment prohibited during the study period;

• Any oral anti-diabetic drugs other than study medication

• 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 (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2x upper limit of normal (ULN));

• Subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)

• 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 with known hypersensitivity to glimepirides, or metformin; Night-shift workers;

• Treatment with any investigational product in the last 3 months before study entry;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Glimepiride

Locations

Country	Name	City	State
Korea, Republic of	Handok	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	Efficacy : Change in HbA1c between baseline and endpoint
Secondary	Efficacy : Change in HbA1c measured at baseline, week 8 and week 16. Change in FPG and PP2h measured at baseline, week 8 and week 16. Response rates in terms of HbA1c, FPG.Patient compliance
Secondary	Safety: episodes of hypoglycemia, adverse events, laboratory values including hematology, blood chemistry and urinalysis, vital sign and physical examination, Frequency with hypoglycemic episode