Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy

NCT01444248 | Completed Phase 4

• 1 other identifier: HANDOK2009.02
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

Conditions

Type 2 Diabetes Mellitus

Keywords

Amaryl MEX

Outcome Measures

Primary Outcomes (1)

• compliance of patients treated with once-daily or twice-daily

  24 weeks

Secondary Outcomes (3)

• Blood glucose lowering effect

  24 weeks

• Episodes of hypoglycaemia

  24 weeks

• other adverse events

  24 weeks

Study Arms (2)

Amaryl MEX

EXPERIMENTAL

Drug: Glimepiride/ Metformin

Amaryl M

ACTIVE COMPARATOR

Drug: Glimepiride/ Metformin

Interventions

Glimepiride/ Metformin DRUG

4/1000mg once daily

Amaryl MEX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 \~ 75 years at screening
• Patients who have been diagnosed with type 2 DM for at least 3 months
• Patients who were treated with a stable dose with combination therapy of glimepiride 4mg or more and metformin 1000mg or more which can switch to Amaryl M 2/500mg bid or Amaryl Mex 2/500mg 2T od regimen.
• HbA1c ≤ 9 % at randomization
• BMI ≤ 40 kg/m2 at randomization
• Patients who would give the informed consent
• Patients who can perform SMBG and record the data on the patient's diary
• Patients who can understand and use MEMS properly

You may not qualify if:

• Patients with the medical history of acute metabolic complications such as diabetic ketoacidosis, hyperosmolar nonketotic coma within 3 months prior to the study participation
• Patients who are under insulin therapy at randomization
• Patients who received systemic corticosteroid agent within 4 weeks prior to the study participation
• Patients with acute, severe cardiovascular disease (e.g., heart failure, myocardial infarction, stroke, etc).
• Pregnant or lactating females
• history of drug or alcohol abuse
• Patients with known hypersensitivity to the ingredient of the study drug or drugs in sulfonylurea, sulfonamide, biguanide class
• Night-shift workers
• Patients with an experience of participating in other clinical trial within 3 months prior to the study participation
• 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
• Any conditions requiring help of others with drug administration (e.g. manual disability, serious visual defect, etc.)

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Handok Pharmaceuticals

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sungwoo Park, professor

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 30, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

KR (1)