NCT00348231

Brief Summary

The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 1, 2006

Status Verified

June 1, 2006

First QC Date

July 3, 2006

Last Update Submit

August 31, 2006

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, biphasic insulin analogue

Outcome Measures

Primary Outcomes (2)

  • HbA1c

  • daily profile of blood glucose

Secondary Outcomes (2)

  • IMT

  • QOL

Interventions

dual-action insulin analogDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Type 2 diabetes
  • secondary failure of SU drug
  • whose age is to 80 from 20 years old

You may not qualify if:

  • who has the complication
  • who has a allergy of insulin
  • who is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine

Tokyo, Tokyo, 1058461, Japan

RECRUITING

Related Publications (1)

  • Miyashita Y, Nishimura R, Nemoto M, Matsudaira T, Kurata H, Yokota T, Yokota K, Tojo K, Utsunomiya K, Tajima N. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure. Cardiovasc Diabetol. 2008 May 29;7:16. doi: 10.1186/1475-2840-7-16.

    PMID: 18507868DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Yumi Miyashita, MD

    The Jikei University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yumi Miyashita, MD

CONTACT

+081334331111yumi-m@jikei.ac.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

November 1, 2004

Study Completion

August 1, 2006

Last Updated

September 1, 2006

Record last verified: 2006-06

Locations

JP(1)