NCT00913367

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

May 26, 2009

Last Update Submit

March 26, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Mean change in HbA1c from baseline to the last visit

    16 weeks

Secondary Outcomes (6)

  • Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events

    16 weeks

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

    16 weeks

  • Mean change in Lantus® dose from baseline to the last visit

    16 weeks

  • Compliance

    16 weeks

  • Frequency with hypoglycemic episode

    16weeks

  • +1 more secondary outcomes

Study Arms (2)

Amaryl group

ACTIVE COMPARATOR
Drug: glimepiride + insulin glargine (Amaryl + Lantus)

Amaryl M group

EXPERIMENTAL
Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)

Interventions

glimepiride + insulin glargine (Amaryl + Lantus)DRUG

* 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

Also known as: Amaryl, Lantus injection solostar
Amaryl group
glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)DRUG

* 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

Also known as: Amaryl M, Lantus injection solostar
Amaryl M group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • %\<HbA1c\<11 % at screening
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HeeYoung Lee

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepirideInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Kang S Park

    Eulji University 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

May 26, 2009

First Posted

June 4, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

KR(1)