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Diabetes MellitusPhase 2PIOrenNCT00770640

Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.

A Phase 2 study testing Pioglitazone and insulin and Insulin in people with Diabetes Mellitus, run by Takeda at 9 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the metabolic and cardiovascular effects of pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2 Diabetes and Renal Failure. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Pioglitazone and insulin and Insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
9 sitesGermany
Study dates
Aug 2008to Jun 2010
Phase
Phase 2
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has Type 2 Diabetes Mellitus, and is a patient on insulin treatment for at least 3 months.
  • Has a body mass index less than 36 kg/m²
  • Has a glycosylated hemoglobin level greater than or equal to 6.0% and less than 10%.
  • Patient is on hemo-dialysis with or without residual excretion
  • An insulin dose greater than 20 IE/day

Who cannot join

  • Has a history of type 1 diabetes.
  • Has acute infections.
  • History of hypersensitivity to the study drugs or to drugs with similar chemical structures.
  • History of severe or multiple allergies.
  • Has a progressive fatal disease other than kidney failure.
  • Has a history of drug or alcohol abuse within the last 5 years.
Show all 19Show fewer
  • A history of significant cardiovascular (e.g. Coronary heart failure based on New York Heart Association stage III - IV), respiratory, gastrointestinal, hepatic (e.g. alanine aminotransferase greater than 2.5 times the normal reference range) or hematological disease.
  • History of primary hyperaldosteronism
  • Acute myocardial infarction, open heart surgery or cerebral event (stroke/transient ischemic attack) within the last year prior to study start.
  • Any further antidiabetic treatment except pioglitazone and insulin.
  • History of macular edema.
  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Treatment with any other investigational drug within 3 months before trial entry.
  • Treatment with steroids within 3 months before trial entry.
  • Treatment with thiazolidinediones within the past 3 months.
  • If statin therapy applicable: Change of medication within the last 4 weeks.
  • Pre-treatment with gemfibrozil within the last 12 weeks.
  • Pre-treatment with rifampicin within the last 12 weeks.
  • Has uncontrolled unstable angina.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Study site

    Alzey, Rhineland-Palatinate

  • Study site

    Bottrop, North Rhine-Westphalia

  • Study site

    Düsseldorf, North Rhine-Westphalia

  • Study site

    Ingelheim, Rhineland-Palatinate

  • Study site

    Lüdenscheid, North Rhine-Westphalia

  • Study site

    Mainz, Rhineland-Palatinate

  • Study site

    Schwetzingen, Baden-Wurttemberg

  • Study site

    Solingen, North Rhine-Westphalia

  • Study site

    Wiesbaden, Hesse

Other trials in Germany

About this study

Official title: Comparison of the Effects of Pioglitazone vs. Placebo When Given in Addition to Standard Insulin Treatment in Patients With Type 2 Diabetes Mellitus and Renal Failure

The purpose of this study is to determine the metabolic and cardiovascular effects of pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2 Diabetes and Renal Failure.

Read the detailed description

Patients with type 2 diabetes mellitus and clinically significant kidney disease presenting with contra-indications for metformin and sulfonylurea drugs are usually treated with insulin therapy only. While the prolonged pharmacokinetic insulin profile due to delayed renal insulin elimination already is a hurdle for a successful therapy, impaired kidney function results in increased oxidative stress and cardiovascular risk, especially in patients requiring dialysis. Several potential mechanisms may explain this increased cardiovascular risk, and one, frequent finding is coexistence of several other independent cardiovascular risk factors including dyslipidemia, hypertension and smoking. In addition, impaired kidney function is associated with elevated markers of inflammation and other putative risk factors for cardiovascular events.

The focus of this study is to investigate whether pioglitazone may help improve overall metabolic and cardiovascular risks in patients with end stage renal disease, and if pioglitazone can potentially exert positive effects on kidney function in patients with renal failure requiring dialysis.

The duration of treatment for patients completing the study is approximately 26 weeks.

Being tested
Pioglitazone and insulin, Insulin
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
Medical subject headings
Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pioglitazone and insulinDrug

    Also called ACTOS®, AD-4833

    Pioglitazone 30 mg, tablets, orally, once daily and variable insulin therapy for up to 24 weeks.

  • InsulinDrug

    Pioglitazone placebo-matching tablets, orally, once daily and variable insulin therapy for up to 24 weeks.

Study groups in NCT00770640
Study groupRoleWhat they receive
Pioglitazone 30mg QDExperimental(and variable insulin therapy)
Receives: Drug: Pioglitazone and insulin
Placebo QDPlacebo comparator(and variable insulin therapy)
Receives: Drug: Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of total daily Insulin Dose.

    Measured: Week 24 or Final Visit.

Secondary outcomes (24)

  1. Individual insulin doses to assess the number of patients with insulin reduction of greater than or equal to 30%.

    Measured: Weeks 12 and 24 or Final Visit.

  2. Change from Baseline in Glycosylated Hemoglobin.

    Measured: Weeks 12 and 24 or Final Visit.

  3. Change from Baseline in Glucose.

    Measured: Weeks 12 and 24 or Final Visit.

  4. Change from Baseline in Insulin.

    Measured: Weeks 12 and 24 or Final Visit.

  5. Change from Baseline in C-peptide.

    Measured: Weeks 12 and 24 or Final Visit.

  6. Change from Baseline in Intact Proinsulin.

    Measured: Weeks 12 and 24 or Final Visit.

  7. Change from Baseline in Adiponectin.

    Measured: Weeks 12 and 24 or Final Visit.

  8. Change from Baseline in Angiotensin.

    Measured: Weeks 12 and 24 or Final Visit.

  9. Change from Baseline in Relaxin.

    Measured: Weeks 12 and 24 or Final Visit.

  10. Change from Baseline in fetuin A.

    Measured: Weeks 12 and 24 or Final Visit.

  11. Change from Baseline in Carbonyl Protein.

    Measured: Weeks 12 and 24 or Final Visit.

  12. Change from Baseline in Myeloperoxidase.

    Measured: Weeks 12 and 24 or Final Visit.

  13. Change from Baseline in Matrix-Gla Protein.

    Measured: Weeks 12 and 24 or Final Visit.

  14. Change from Baseline in High Sensitivity C-reactive Protein.

    Measured: Weeks 12 and 24 or Final Visit.

  15. Change from Baseline in Cholesterol.

    Measured: Weeks 12 and 24 or Final Visit.

  16. Change from Baseline in High-Density Lipoprotein.

    Measured: Weeks 12 and 24 or Final Visit.

  17. Change from Baseline in Low-Density Lipoprotein.

    Measured: Weeks 12 and 24 or Final Visit.

  18. Change from Baseline in Oxidized Low-Density Lipoprotein.

    Measured: Weeks 12 and 24 or Final Visit.

  19. Change from Baseline in Triglycerides.

    Measured: Weeks 12 and 24 or Final Visit.

  20. Change from Baseline in Matrix Metalloproteinase -9.

    Measured: Weeks 12 and 24 or Final Visit.

  21. Change from Baseline in Monocyte Chemoattractant Protein -1.

    Measured: Weeks 12 and 24 or Final Visit.

  22. Change from Baseline in E-selectin.

    Measured: Weeks 12 and 24 or Final Visit.

  23. Pioglitazone in serum.

    Measured: Week 12.

  24. Change from Baseline in intact Parathyroid Hormone.

    Measured: Weeks 12 and 24 or Final Visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00770640
Sponsor's protocol ID
ATS K029
Other IDs
2007-006744-21, DE-PIO-029, U1111-1114-1645
Acronym
PIOren
Status last verified
Aug 2010
First submitted
9 Oct 2008
Last updated
1 Sep 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone and insulin and Insulin in people with Diabetes Mellitus, run by Takeda at 9 sites in Germany.

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 19 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: finished, as of the sponsor's last update on 1 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of total daily Insulin Dose. (time frame: Week 24 or Final Visit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00770640.

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 1 Sep 2010.

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