Shiga Progression of Diabetes, Nephropathy and Retinopathy | NCT00846716

Studies
Shiga Progression of Diabetes, Nephropathy and Retinopathy

NCT00846716

Sponsor

Shiga University

Status

Unknown status

Last Update Posted

Feb 19, 2009Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

Pioglitazone add on to SU or biguanide
SU or Biguanide

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Nov 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Dec 11, 2008

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2009

Last Update Posted Date

Feb 19, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Shiga UniversityOTHER

Collaborators

Name	Class
Kanazawa Medical University	OTHER
Nagahama Red Cross Hospital	OTHER
Nagahama City Hospital	OTHER
Kohka Public Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

2. Outcome measures:

Primary endpoint Onset or progression of diabetic nephropathy
Secondary endpoints (1)Progression of diabetes mellitus (2)Change in HbA1c (3)Change in albumin-creatinine ratio (4)Change in GFR (5)CHange in cystatin C

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone add on to SU or biguanide	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset and progression of diabetic nephropathy		2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hiroshi Maegawa, PhD	Contact	+81-77-548-2222		maegawa@belle.shiga-med.ac.jp
Takashi Uzu, PhD	Contact	+81-77-548-2222		tuzu@belle.shiga-med.ac.jp

Overall Officials

Name	Affiliation	Role
Atsunori Kashiwagi, PhD.	Tsukiwa-machi, Seta, Otsu, Shiga, Japan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiga University of Medical Science	Recruiting	Ōtsu	Shiga	520-2192	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003928	Diabetic Nephropathies
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001645	Biguanides

Ancestor Terms

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided