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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00437554
• Lead Sponsor: Handok Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Study Completion: 2007-07
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy : Change in HbA1c between baseline and endpoint

Secondary Outcome Measures

Name	Time	Method
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
Safety: episodes of hypoglycemia, adverse events, laboratory values including hematology, blood chemistry and urinalysis, vital sign and physical examination, Frequency with hypoglycemic episode

Trial Locations

Locations (1)

Handok; 🇰🇷 Seoul, Korea, Republic of