Type 2 Diabetes MellitusSHIP-DINERNCT00846716
Shiga Progression of Diabetes, Nephropathy and Retinopathy
A study testing Pioglitazone add on to SU or biguanide and SU or Biguanide in people with Type 2 Diabetes Mellitus, run by Shiga University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pioglitazone add on to SU or biguanide and SU or Biguanide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Shiga University of Medical Science
Ōtsu, Shiga, 520-2192
Hiroshi Maegawa, PhD, +81-77-548-2222, maegawa@belle.shiga-med.ac.jp
Takashi Uzu, PhD, +81-77-548-2222, tuzu@belle.shiga-med.ac.jp
About this study
Official title: Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on
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.
Read the detailed description
- 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
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone add on to SU or biguanide, SU or Biguanide
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Retinopathy, pioglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
SU or BiguanideDrug
As an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone add on to SU or biguanide | Experimental | Not described Receives: Drug: Pioglitazone add on to SU or biguanide |
| SU or Biguanide | Active comparator | Not described Receives: Drug: SU or Biguanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset and progression of diabetic nephropathy
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiga University
- Sponsor type
- University, hospital or other
- Collaborators
- Kanazawa Medical University, Nagahama Red Cross Hospital, Nagahama City Hospital, Kohka Public Hospital, Second Okamoto General Hospital, Omihachiman COmmunity Medical Center, Yasu Hospital, Toyosato Hospital, Ako City Hospital, Horide Clinic, Kawabata Clinic, Seta Clinic, Shiga Clinic, Osaka University, NTT West Osaka Hospital, Hyogo prefectural Amagasaki Hospital, Tomita Clinic, Sawada Clinic, Social Insurance Shiga Hospital
- Investigators
- Atsunori Kashiwagi, PhD., Study chair, Tsukiwa-machi, Seta, Otsu, Shiga, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846716
- Sponsor's protocol ID
- 2008.9.18 ver2-4
- Acronym
- SHIP-DINER
- Status last verified
- Feb 2009
- First submitted
- 11 Dec 2008
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on
- ClinicalTrials.gov ID
- NCT00846716
- Acronym / sponsor ID
- SHIP-DINER / 2008.9.18 ver2-4
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Diabetic Retinopathy, pioglitazone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shiga UniversityUniversity, hospital or other
- Collaborators
- Kanazawa Medical University, Nagahama Red Cross Hospital, Nagahama City Hospital, Kohka Public Hospital, Second Okamoto General Hospital, Omihachiman COmmunity Medical Center, Yasu Hospital, Toyosato Hospital, Ako City Hospital, Horide Clinic, Kawabata Clinic, Seta Clinic, Shiga Clinic, Osaka University, NTT West Osaka Hospital, Hyogo prefectural Amagasaki Hospital, Tomita Clinic, Sawada Clinic, Social Insurance Shiga Hospital
- Study start
- Mar 2008
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone add on to SU or biguanideAs an initial dosing, 15mg/day of pioglitazone is administered to the patients for 2 years, who are taking SU or biguanide. | Drug | Pioglitazone add on to SU or biguanide |
| SU or BiguanideAs an initial dose,a common dose of SU or biguanide is administered to the patients for 2 years. | Drug | SU or Biguanide |
Primary outcome
Onset and progression of diabetic nephropathy
Time frame: 2 years
1 secondary outcome
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
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atsunori Kashiwagi, PhD. study chair
Tsukiwa-machi, Seta, Otsu, Shiga, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone add on to SU or biguanide and SU or Biguanide in people with Type 2 Diabetes Mellitus, run by Shiga University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroshi Maegawa, PhD (+81-77-548-2222, maegawa@belle.shiga-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset and progression of diabetic nephropathy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009.