Efficacy of Pioglitazone and Metformin on Cardiovascular Risk in Subjects With Insulin-Treated Type 2 Diabetes Mellitus.
PIOcomb
Impact of Pioglitazone, Metformin and the Combination of Both on Cardiovascular Risk in Insulin-treated Patients With Type 2 Diabetes - The PIOcomb Study
4 other identifiers
interventional
121
1 country
18
Brief Summary
The purpose of this study is to determine the Anti-Inflammation Effects of Pioglitazone, twice daily (BID), and Pioglitazone/Metformin Combination Therapy BID in Type 2 Diabetes Subjects Treated with Insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus
Started May 2008
Typical duration for phase_4 diabetes-mellitus
18 active sites
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
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedAugust 18, 2010
August 1, 2010
2.2 years
October 9, 2008
August 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Matrix Metallo Proteinase 9.
The change between Matrix Metallo Proteinase 9 collected at final visit or week 24 and Matrix Metallo Proteinase 9 collected at baseline.
Baseline and Week 24.
Secondary Outcomes (44)
Change from Baseline in 24-hour Blood Pressure Profile.
Baseline and Week 24.
Change from Baseline in Intima Media Thickness.
Baseline and Week 24.
Change from Baseline in 24-hour Urinary Sample.
Baseline and Week 24.
Change from Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide.
Baseline and Week 24.
Change from Baseline in 8-iso Prostaglandin F2 alpha.
Baseline and Week 24.
- +39 more secondary outcomes
Study Arms (3)
Pioglitazone 15mg BID
EXPERIMENTALInsulin therapy added
Pioglitazone 15mg + Metformin 850mg BID
EXPERIMENTALInsulin Therapy Added
Metformin 850mg BID
ACTIVE COMPARATORInsulin therapy added
Interventions
Pioglitazone 15 mg, tablets, orally, twice daily and metformin placebo-matching tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
Pioglitazone 15 mg, tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
Pioglitazone placebo-matching tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
Eligibility Criteria
You may qualify if:
- Has Diabetes Mellitus type 2.
- A glycosylated hemoglobin level greater than or equal to 6.5% and less than 8.5%.
- Treatment with the following insulins with or without Oral Antidiabetic Therapy since 3 months:
- Long acting basal insulin analogs
- NPH insulin
- Combination insulin with 1-2 daily doses except intensified insulin therapies.
- A body mass index greater than or equal to 25.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
You may not qualify if:
- Has a history of type 1 diabetes mellitus.
- Has uncontrolled hypertension (systolic blood pressure greater than 160mmHg and/or diastolic blood pressure greater than 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
- Has acute infections.
- Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
- Has a history of severe or multiple allergies.
- History of drug or alcohol abuse in the past 5 years
- A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.2 mg/dL in women and greater than 1.5 mg/dL in men, Glomerular Filtration Rate less than 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator
- History of macular edema.
- State after kidney transplantation.
- Serum potassium greater than 5.5 mmol/L.
- History of primary hyperaldosteronism.
- Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
- 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:
- Pre-treatment with gemfibrozil within the last 12 weeks.
- Pre-treatment with rifampicin within the last 12 weeks.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (18)
Unknown Facility
Lichtenfels, Bavaria, Germany
Unknown Facility
Hamburg, Hamburg, Germany
Unknown Facility
Frankfurt am Main, Hesse, Germany
Unknown Facility
Kassel, Hesse, Germany
Unknown Facility
Wiesbaden, Hesse, Germany
Unknown Facility
Bad Oeynhausen, North Rhine-Westphalia, Germany
Unknown Facility
Dinslaken, North Rhine-Westphalia, Germany
Unknown Facility
Duisburg, North Rhine-Westphalia, Germany
Unknown Facility
Essen, North Rhine-Westphalia, Germany
Unknown Facility
Münster, North Rhine-Westphalia, Germany
Unknown Facility
Wuppertal, North Rhine-Westphalia, Germany
Unknown Facility
Diez, Rhineland-Palatinate, Germany
Unknown Facility
Landau, Rhineland-Palatinate, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, Germany
Unknown Facility
Dresden, Saxony, Germany
Unknown Facility
Leipzig, Saxony, Germany
Unknown Facility
Berlin, State of Berlin, Germany
Unknown Facility
Jena, Thuringia, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda Pharma GmbH, Aachen (Germany)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
August 18, 2010
Record last verified: 2010-08