Diabetes MellitusPhase 4PIOcombNCT00770445
Efficacy of Pioglitazone and Metformin on Cardiovascular Risk in Subjects With Insulin-Treated Type 2 Diabetes Mellitus.
A Phase 4 study testing Pioglitazone and insulin, Pioglitazone and metformin and insulin and Metformin and insulin in people with Diabetes Mellitus, run by Takeda at 18 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pioglitazone and insulin, Pioglitazone and metformin and insulin and Metformin and insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 18 sitesGermany
- Study dates
- May 2008to Jul 2010
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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.
- Treatment with thiazolidinediones within the past 3 months.
- If statin therapy applicable: Change of medication within the last 4 weeks.
- Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
- Treatment with any other investigational drug within 4 weeks before trial entry.
- Any elective surgery during study participation.
- Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
- History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
- Acute or scheduled investigation with iodine containing radiopaque material.
- Uncontrolled unstable angina pectoris.
- Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Study site
Bad Oeynhausen, North Rhine-Westphalia
Study site
Berlin, State of Berlin
Study site
Diez, Rhineland-Palatinate
Study site
Dinslaken, North Rhine-Westphalia
Study site
Dresden, Saxony
Study site
Duisburg, North Rhine-Westphalia
Study site
Essen, North Rhine-Westphalia
Study site
Frankfurt am Main, Hesse
Study site
Hamburg, Free and Hanseatic City of Hamburg
Study site
Jena, Thuringia
Study site
Kassel, Hesse
Study site
Landau, Rhineland-Palatinate
Study site
Leipzig, Saxony
Study site
Lichtenfels, Bavaria
Study site
Mainz, Rhineland-Palatinate
Study site
Münster, North Rhine-Westphalia
Study site
Wiesbaden, Hesse
Study site
Wuppertal, North Rhine-Westphalia
About this study
Official title: Impact of Pioglitazone, Metformin and the Combination of Both on Cardiovascular Risk in Insulin-treated Patients With Type 2 Diabetes - The PIOcomb Study
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.
Read the detailed description
It is established that matrix metalloproteinases play an essential role in the degradation of collagen and other extra cellular matrix macromolecules. In addition, matrix metalloproteinases are implicated in plaque rupture through their capacity to thin the protective cap of the plaque, thus rendering it more vulnerable. In fact, matrix metalloproteinase-9 levels are elevated in patients with unstable plaques and in patients with acute coronary syndrome. In patients with type 2 diabetes mellitus, matrix metalloproteinase-1 and matrix metalloproteinase-9 levels are usually elevated and the atherosclerotic plaques are more vulnerable compared to non-diabetic patients, confirming the role of this proteinase in the development of acute coronary syndrome. Therefore, therapeutic strategies that reduce blood glucose levels and attenuate inflammation and matrix metalloproteinases activity may be a tool for reducing cardiovascular risk in patients with diabetes.
The purpose of this trial is to investigate whether the anti-inflammatory effects of pioglitazone are maintained and sustained over a longer observation period when given in combination with insulin in comparison to the metformin plus insulin combination. The duration of treatment for patients completing the study is approximately 6 months.
- Conditions
- Diabetes Mellitus
- Being tested
- Pioglitazone and insulin, Pioglitazone and metformin and insulin, Metformin and 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®
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 and metformin and insulinDrug
Also called ACTOS®
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.
Metformin and insulinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone 15mg BID | Experimental | Insulin therapy added Receives: Drug: Pioglitazone and insulin |
| Pioglitazone 15mg + Metformin 850mg BID | Experimental | Insulin Therapy Added Receives: Drug: Pioglitazone and metformin and insulin |
| Metformin 850mg BID | Active comparator | Insulin therapy added Receives: Drug: Metformin and insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 24.
Secondary outcomes (44)
Change from Baseline in 24-hour Blood Pressure Profile.
The change between the 24-hour Blood Pressure Profile recorded at final visit or week 24 and 24-hour Blood Pressure Profile recorded at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Intima Media Thickness.
The change between the value of Intima Media Thickness measured at final visit or week 24 and Intima Media Thickness measured at baseline.
Measured: Baseline and Week 24.
Change from Baseline in 24-hour Urinary Sample.
The change between the value of urine participants collect 24 hours before final visit or week 24 and urine participants collect 24 hours before baseline.
Measured: Baseline and Week 24.
Change from Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide.
The change between the value of N-terminal Pro-hormone Brain Natriuretic Peptide collected at final visit or week 24 and N-terminal Pro-hormone Brain Natriuretic Peptide collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in 8-iso Prostaglandin F2 alpha.
The change between the value of 8-iso Prostaglandin F2 alpha collected at final visit or week 24 and 8-iso Prostaglandin F2 alpha collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Albumin.
The change between the value of Albumin collected at final visit or week 24 and Albumin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Creatinine.
The change between the value of Creatinine collected at final visit or week 24 and Creatinine collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in C/A-quotient.
The change between the value of C/A-quotient collected at final visit or week 24 and C/A-quotient collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Homeostasis Model Assessment - Insulin Sensitivity.
The change between Homeostasis Model Assessment of Insulin Sensitivity collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Sensitivity collected at baseline. Homeostatis Model Assessment measures insulin sensitivity, calculated by fasting insulin times fasting glucose, divided by a constant (22.5).
Measured: Baseline and Week 24.
Change from Baseline in Total Cholesterol.
The change between the value of Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Low-Density Lipoprotein.
The change between the value of Low-Density Lipoprotein collected at final visit or week 24 and Low-Density Lipoprotein collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in High-Density Lipoprotein.
The change between the value of High-Density Lipoprotein collected at final visit or week 24 and High-Density Lipoprotein collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Triglycerides.
The change between the value of Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Glycosylated Hemoglobin.
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Glucose.
The change between the value of Glucose collected at final visit or week 24 and Glucose collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Insulin.
The change between the value of Insulin collected at final visit or week 24 and Insulin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Intact Proinsulin.
The change between the value of Intact Proinsulin collected at final visit or week 24 and Intact Proinsulin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in C-peptide.
The change between the value of C-peptide collected at final visit or week 24 and C-peptide collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Adiponectin.
The change between the value of Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in High Molecular Weight Adiponectin.
The change between the value of High Molecular Weight Adiponectin collected at final visit or week 24 and High Molecular Weight Adiponectin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in High-Sensitivity C-Reactive Protein.
The change between the value of High-Sensitivity C-Reactive Protein collected at final visit or week 24 and High-Sensitivity C-Reactive Protein collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Fibrinogen.
The change between the value of Fibrinogen collected at final visit or week 24 and Fibrinogen collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in E-selectin
The change between the value of E-selectin collected at final visit or week 24 and E-selectin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Nuclear Factor-kappa B.
The change between the value of Nuclear Factor-kappa B collected at final visit or week 24 and Nuclear Factor-kappa B collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Plasminogen Activator Inhibitor-1.
The change between the value of Plasminogen Activator Inhibitor-1 collected at final visit or week 24 and Plasminogen Activator Inhibitor-1 collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Nitrotyrosine.
The change between the value of Nitrotyrosine collected at final visit or week 24 and Nitrotyrosine collected at baseline.
Measured: Baseline and Week 24.
Change from baseline in Insulin Consumption.
The change between the value of Insulin collected at final visit or week 24 and Insulin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Endothelial Function measured by Laser-Doppler-flowmetry.
The change between the value of Endothelial Function measured at final visit or week 24 and Endothelial Function measured at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Body Weight.
The change between the value of the participant's Body Weight recorded at final visit or week 24 and the participant's Body Weight recorded at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Electrocardiograms
The change between the value of Electrocardiograms measured at final visit or week 24 and Electrocardiograms measured at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Alanine Aminotransferase Laboratory Safety Variable.
The change between the value of Alanine Aminotransferase collected at final visit or week 24 and Alanine Aminotransferase collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Aspartate Aminotransferase Laboratory Safety Variable.
The change between the value of Aspartate Aminotransferase collected at final visit or week 24 and Aspartate Aminotransferase collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Gamma-glutamyl transferase Laboratory Safety Variable.
The change between the value of Gamma-glutamyl transferase collected at final visit or week 24 and Gamma-glutamyl transferase collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Glomerular Filtration Rate Laboratory Safety Variable.
The change between the value of Glomerular Filtration Rate collected at final visit or week 24 and Glomerular Filtration Rate collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Alkaline Phosphatase Laboratory Safety Variable.
The change between the value of Alkaline Phosphatase collected at final visit or week 24 and Alkaline Phosphatase collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Leucocytes Laboratory Safety Variable.
The change between the value of Leucocytes collected at final visit or week 24 and Leucocytes collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Hemoglobin Laboratory Safety Variable.
The change between the value of Hemoglobin collected at final visit or week 24 and Hemoglobin collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Thrombocytes Laboratory Safety Variable.
The change between the value of Thrombocytes collected at final visit or week 24 and Thrombocytes collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Creatinine Kinase Laboratory Safety Variable.
The change between the value of Creatinine Kinase collected at final visit or week 24 and Creatinine Kinase collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Creatinine Laboratory Safety Variable.
The change between the value of Creatinine collected at final visit or week 24 and Creatinine collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Capillary Blood Glucose Laboratory Safety Variable.
The change between the value of Capillary Blood Glucose collected at final visit or week 24 and Capillary Blood Glucose collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Potassium Laboratory Safety Variable.
The change between the value of Potassium collected at final visit or week 24 and Potassium collected at baseline.
Measured: Baseline and Week 24.
Change from Baseline in Circadian (7 point) Blood Glucose Profile (Week 24).
The change between Circadian Blood Glucose measured before week 24 or final visit and Circadian Blood Glucose measured before baseline. Participants measure their blood glucose levels 7 times (before and after breakfast, before and after lunch, before and after dinner and before going to bed) on two arbitrary days and record these measurements in their diaries.
Measured: Baseline and Week 24.
Change from Baseline in Circadian (7 point) Blood Glucose Profile (Week 12).
The change between Circadian Blood Glucose measured before week 12 and Circadian Blood Glucose measured before baseline. Participants measure their blood glucose levels 7 times (before and after breakfast, before and after lunch, before and after dinner and before going to bed) on two arbitrary days and record these measurements in their diaries.
Measured: Baseline and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda Pharma GmbH, Aachen (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770445
- Sponsor's protocol ID
- ATS K028
- Other IDs
- 2007-006706-14, DE-PIO-028, U1111-1113-1888
- Acronym
- PIOcomb
- Status last verified
- Aug 2010
- First submitted
- 9 Oct 2008
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pioglitazone, Metformin and the Combination of Both on Cardiovascular Risk in Insulin-treated Patients With Type 2 Diabetes - The PIOcomb Study
- ClinicalTrials.gov ID
- NCT00770445
- Acronym / sponsor ID
- PIOcomb / ATS K028
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Oct 2008 (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 determine the Anti-Inflammation Effects of Pioglitazone, twice daily (BID), and Pioglitazone/Metformin Combination Therapy BID in Type 2 Diabetes Subjects Treated with Insulin.
Detailed description
It is established that matrix metalloproteinases play an essential role in the degradation of collagen and other extra cellular matrix macromolecules. In addition, matrix metalloproteinases are implicated in plaque rupture through their capacity to thin the protective cap of the plaque, thus rendering it more vulnerable. In fact, matrix metalloproteinase-9 levels are elevated in patients with unstable plaques and in patients with acute coronary syndrome. In patients with type 2 diabetes mellitus, matrix metalloproteinase-1 and matrix metalloproteinase-9 levels are usually elevated and the atherosclerotic plaques are more vulnerable compared to non-diabetic patients, confirming the role of this proteinase in the development of acute coronary syndrome. Therefore, therapeutic strategies that reduce blood glucose levels and attenuate inflammation and matrix metalloproteinases activity may be a tool for reducing cardiovascular risk in patients with diabetes.
The purpose of this trial is to investigate whether the anti-inflammatory effects of pioglitazone are maintained and sustained over a longer observation period when given in combination with insulin in comparison to the metformin plus insulin combination. The duration of treatment for patients completing the study is approximately 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone 15mg BID | Experimental | Drug: Pioglitazone and insulinInsulin therapy added |
| Pioglitazone 15mg + Metformin 850mg BID | Experimental | Drug: Pioglitazone and metformin and insulinInsulin Therapy Added |
| Metformin 850mg BID | Active comparator | Drug: Metformin and insulinInsulin therapy added |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (25 listed)
- 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.
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 and insulinAlso: ACTOS®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. | Drug | Pioglitazone 15mg BID |
| Pioglitazone and metformin and insulinAlso: ACTOS®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. | Drug | Pioglitazone 15mg + Metformin 850mg BID |
| Metformin and insulinPioglitazone placebo-matching tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks. | Drug | Metformin 850mg BID |
Primary outcome
Change from Baseline in Matrix Metallo Proteinase 9.
Time frame: Baseline and Week 24.
The change between Matrix Metallo Proteinase 9 collected at final visit or week 24 and Matrix Metallo Proteinase 9 collected at baseline.
44 secondary outcomes
Change from Baseline in 24-hour Blood Pressure Profile.
Time frame: Baseline and Week 24.
Change from Baseline in Intima Media Thickness.
Time frame: Baseline and Week 24.
Change from Baseline in 24-hour Urinary Sample.
Time frame: Baseline and Week 24.
Change from Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide.
Time frame: Baseline and Week 24.
Change from Baseline in 8-iso Prostaglandin F2 alpha.
Time frame: Baseline and Week 24.
Change from Baseline in Albumin.
Time frame: Baseline and Week 24.
Change from Baseline in Creatinine.
Time frame: Baseline and Week 24.
Change from Baseline in C/A-quotient.
Time frame: Baseline and Week 24.
Change from Baseline in Homeostasis Model Assessment - Insulin Sensitivity.
Time frame: Baseline and Week 24.
Change from Baseline in Total Cholesterol.
Time frame: Baseline and Week 24.
Change from Baseline in Low-Density Lipoprotein.
Time frame: Baseline and Week 24.
Change from Baseline in High-Density Lipoprotein.
Time frame: Baseline and Week 24.
Change from Baseline in Triglycerides.
Time frame: Baseline and Week 24.
Change from Baseline in Glycosylated Hemoglobin.
Time frame: Baseline and Week 24.
Change from Baseline in Glucose.
Time frame: Baseline and Week 24.
Change from Baseline in Insulin.
Time frame: Baseline and Week 24.
Change from Baseline in Intact Proinsulin.
Time frame: Baseline and Week 24.
Change from Baseline in C-peptide.
Time frame: Baseline and Week 24.
Change from Baseline in Adiponectin.
Time frame: Baseline and Week 24.
Change from Baseline in High Molecular Weight Adiponectin.
Time frame: Baseline and Week 24.
Change from Baseline in High-Sensitivity C-Reactive Protein.
Time frame: Baseline and Week 24.
Change from Baseline in Fibrinogen.
Time frame: Baseline and Week 24.
Change from Baseline in E-selectin
Time frame: Baseline and Week 24.
Change from Baseline in Nuclear Factor-kappa B.
Time frame: Baseline and Week 24.
Change from Baseline in Plasminogen Activator Inhibitor-1.
Time frame: Baseline and Week 24.
Change from Baseline in Nitrotyrosine.
Time frame: Baseline and Week 24.
Change from baseline in Insulin Consumption.
Time frame: Baseline and Week 24.
Change from Baseline in Endothelial Function measured by Laser-Doppler-flowmetry.
Time frame: Baseline and Week 24.
Change from Baseline in Body Weight.
Time frame: Baseline and Week 24.
Change from Baseline in Electrocardiograms
Time frame: Baseline and Week 24.
Change from Baseline in Alanine Aminotransferase Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Aspartate Aminotransferase Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Gamma-glutamyl transferase Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Glomerular Filtration Rate Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Alkaline Phosphatase Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Leucocytes Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Hemoglobin Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Thrombocytes Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Creatinine Kinase Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Change from Baseline in Creatinine Laboratory Safety Variable.
Time frame: Baseline and Week 24.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
- ACTOSPLUS MET® Package InsertLink provided by the sponsor.
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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.
Medical Director study director
Takeda Pharma GmbH, Aachen (Germany)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone and insulin, Pioglitazone and metformin and insulin and Metformin and insulin in people with Diabetes Mellitus, run by Takeda at 18 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 8 inclusion and 25 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 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 from Baseline in Matrix Metallo Proteinase 9. (time frame: Baseline and Week 24.). 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 18 Aug 2010.