NCT00846716

Brief Summary

The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese type 2 diabetic patients.

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
400

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable type-2-diabetes-mellitus

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

March 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

3.7 years

First QC Date

December 11, 2008

Last Update Submit

February 18, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusDiabetic NephropathyDiabetic Retinopathypioglitazone

Outcome Measures

Primary Outcomes (1)

  • Onset and progression of diabetic nephropathy

    2 years

Secondary Outcomes (1)

  • Progression of diabetes mellitus change from the baseline in HbA1c change from the baseline in albumine/creatinine ratio change from the baseline in cystatin C onset and progression of diabetic retinopathy safety assessment

    2 years

Study Arms (2)

Pioglitazone add on to SU or biguanide

EXPERIMENTAL
Drug: Pioglitazone add on to SU or biguanide

SU or Biguanide

ACTIVE COMPARATOR
Drug: SU or Biguanide

Interventions

Pioglitazone add on to SU or biguanideDRUG

As an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide.

Pioglitazone add on to SU or biguanide
SU or BiguanideDRUG

As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.

SU or Biguanide

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus
  • Less than 8.0% in HbA1c
  • Less than 300 mg/g Cr of urinary albumine level
  • Concomitant therapy with SU and/or Biguanide
  • Untreated hypertension and hypertension treated with ARB or ACEI

You may not qualify if:

  • History of heart failure and concomitant heart failure
  • History of administration of TZD agent
  • Severe hepatic dysfunction with more than 3 times higher than upper limit of normal range of GOT, GPT or rGPT
  • Severe renal dysfunction with more than 2.5 of Cr
  • History of AE with TZD agent
  • Insulin treatment
  • Concomitant urinary track infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiga University of Medical Science

Ōtsu, Shiga, 520-2192, Japan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic NephropathiesDiabetic Retinopathy

Interventions

Biguanides

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic Chemicals

Study Officials

  • Atsunori Kashiwagi, PhD.

    Tsukiwa-machi, Seta, Otsu, Shiga, Japan

    STUDY CHAIR

Central Study Contacts

Hiroshi Maegawa, PhD

CONTACT

+81-77-548-2222maegawa@belle.shiga-med.ac.jp

Takashi Uzu, PhD

CONTACT

+81-77-548-2222tuzu@belle.shiga-med.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

December 11, 2008

First Posted

February 19, 2009

Study Start

March 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

JP(1)