NCT00642915

Brief Summary

To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jun 2003

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

June 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

First QC Date

March 19, 2008

Last Update Submit

August 22, 2008

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy

    Hemoglobin A1c values were measured at Screening and at every visit thereafter.

Secondary Outcomes (1)

  • Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy

    24 weeks

Interventions

Lantus, AmarylDRUG
Also known as: insulin glargine,glimepiride

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs.
  • Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

São Paulo, Brazil

Location

Related Publications (1)

  • Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. doi: 10.1016/j.diabres.2007.08.007. Epub 2007 Oct 4.

    PMID: 17919763BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargineglimepiride

Condition Hierarchy (Ancestors)

Glucose 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

  • Tadaaki Karino

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

June 1, 2003

Study Completion

July 1, 2004

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

BR(1)