Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM

NCT00612144 | Completed Phase 4

• 1 other identifier: GLIME_L_02861
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 DM

Outcome Measures

Primary Outcomes (1)

• Adjusted mean changes in HbA1c from baseline to the last visit

  12~24 weeks

Secondary Outcomes (5)

• Adjusted mean changes in FPG from baseline to the last visit

  12~24 weeks

• Response rate based on HbA1c and FPG levels measured at the last visit

  12~24 weeks

• Frequency with hypoglycemic episode

  12~24 weeks

• Adverse event

  12~24 weeks

• Abnormal change from baseline in clinical laboratory

  12~24 weeks

Study Arms (2)

1

EXPERIMENTAL

Amaryl M group

Drug: Glimepiride/metformin fixed combination

2

ACTIVE COMPARATOR

Metformin group

Drug: Metformin HCl

Interventions

Glimepiride/metformin fixed combination DRUG

Amaryl M 1/250mg\~4/1000mg bid for 12\~26 weeks * Maintenance dose for 10 weeks after 2\~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG

Also known as: Amaryl M

1

Metformin HCl DRUG

Metformin HCl 500mg\~1250mg bid for 12\~26 weeks * Maintenance dose for 10 weeks after 2\~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG

Also known as: Diabex

2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 30 to 75 at the time of screening visit
• Subjects with type 2 DM diagnosed for at least 3 months before screening
• Subjects with type 2 DM treated with monotherapy of 500mg ≤ metformin ≤ 1000mg for at lest 4 weeks prior to screening
• HbA1c ≥ 7.0% but ≤ 10.0% at the time of screening visit
• kg/m2 ≤ BMI ≤ 40 kg/m2
• A negative pregnancy test for all females of childbearing potential
• Provision of signed and dated informed consent prior to any study procedures
• Ability and willingness to perform SMBG and record the data on the subject's diary

You may not qualify if:

• A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
• Current therapy with anti-hyperglycemic agents (except metformin) use in the 4 weeks (8 weeks in case of thiazolidinedione) before screening
• Concomitant treatment prohibited during the study period
• Any oral hypoglycemic agent other than glimepiride, metformin HCl, and fixed-dose combination of glimepiride and metformin HCl
• 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 (ALT and AST \> 2x ULN)
• 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 who have a history of noncompliance with regards to follow-up medical care
• Subjects with known hypersensitivity to glimepiride, metformin HCL
• Night-shift workers
• Treatment with any investigational product in the last 3 months before study entry
• Others; subjects who have participated in this study

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Handok Pharmaceuticals, Co., LTD

Seoul, South Korea

Location

Related Publications (1)

• Kim HS, Kim DM, Cha BS, Park TS, Kim KA, Kim DL, Chung CH, Park JH, Jang HC, Choi DS. Efficacy of glimepiride/metformin fixed-dose combination vs metformin uptitration in type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea. J Diabetes Investig. 2014 Nov;5(6):701-8. doi: 10.1111/jdi.12201. Epub 2014 Mar 16.

  PMID: 25422771 DERIVED

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

• Dong Seob CHOI

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: February 11, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

KR (1)