Diabetes MellitusPhase 3NCT00727857
Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
A Phase 3 study testing Pioglitazone and metformin, Pioglitazone and Metformin in people with Diabetes Mellitus, run by Takeda at 77 sites in 4 countries.
Trial summary
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pioglitazone and metformin, Pioglitazone and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 77 sitesin 4 countries
- Study dates
- Jun 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has type 2 diabetes.
- Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.
- A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.
- Body mass index less than or equal to 45 kg/m2.
- Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
- 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.
- Stable condition as determined by a physician.
Who cannot join
- Type 1 diabetes.
- Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
- History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.
- Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.
- Has a triglyceride level greater than 500 mg per dL.
- Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL.
Show all 18Show fewer
- Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening.
- Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
- Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
- History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
- Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
- Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Antidiabetic medications other than study medication
- Chronically used oral or parenteral glucocorticoids
- Niacin greater than 200 mg per day, including niacin-containing products such as Advicor
- Chronically used steroid-joint injections
Trial locations and contacts
77 sites in 4 countries.
77 sites in 4 countries
United States66 sites
Study site
Altamonte Springs, Florida
Study site
Anaheim, California
Study site
Artesia, California
Study site
Billings, Montana
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Bountiful, Utah
Study site
Chesterfield, Missouri
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Coeur d'Alene, Idaho
Study site
Columbus, Georgia
Study site
Coral Gables, Florida
Study site
Corpus Christi, Texas
Study site
Cranston, Rhode Island
Study site
Dallas, Texas
Study site
Dinuba, California
Study site
Durham, North Carolina
Study site
El Paso, Texas
Study site
Elizabeth, New Jersey
Study site
Elkhart, Indiana
Study site
Eugene, Oregon
Study site
Fayetteville, New York
Study site
Fayetteville, Tennessee
Study site
Fleetwood, Pennsylvania
Study site
Flossmoor, Illinois
Study site
Haleyville, Alabama
Study site
Hialeah, Florida
Study site
Houston, Texas
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
McAllen, Texas
Study site
Miami, Florida
Study site
Mission, Texas
Study site
Montgomery, Alabama
Study site
New Braunfels, Texas
Study site
New York, New York
Study site
Norristown, Pennsylvania
Study site
North Richland Hills, Texas
Study site
Norwalk, California
Study site
Oklahoma City, Oklahoma
Study site
Orange, California
Study site
Panama City, Florida
Study site
Pell City, Alabama
Study site
Peoria, Illinois
Study site
Perrysburg, Ohio
Study site
Petersburg, Virginia
Study site
Phoenix, Arizona
Study site
Pinehurst, North Carolina
Study site
Plantation, Florida
Study site
Port Orchard, Washington
Study site
Pueblo, Colorado
Study site
Saint Cloud, Florida
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Ana, California
Study site
Santa Monica, California
Study site
Shawnee, Kansas
Study site
Simpsonville, South Carolina
Study site
Southfield, Michigan
Study site
Spokane, Washington
Study site
St. Petersburg, Florida
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Varnville, South Carolina
Study site
Zanesville, Ohio
Puerto Rico7 sites
Study site
Aibonito
Study site
Caguas
Study site
Ciales
Study site
Coto Laurel
Study site
Guayma
Study site
Guaynabo
Study site
Rio Piedras
About this study
Official title: A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
Read the detailed description
Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism.
Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents.
This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.
Study participation is anticipated to be approximately 6.5 months.
- Conditions
- Diabetes Mellitus
- Being tested
- Pioglitazone and metformin, Pioglitazone, Metformin
- 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 metforminDrug
Also called ACTOPLUS MET
Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.
PioglitazoneDrug
Also called ACTOS®, AD4833
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.
MetforminDrug
Also called Fortamet, Glucophage, Glucophage XR, Glumetza
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone 15 mg /Metformin 850 mg BID | Experimental | Not described Receives: Drug: Pioglitazone and metformin |
| Pioglitazone 15 mg BID | Active comparator | Not described Receives: Drug: Pioglitazone |
| Metformin 850 mg BID | Active comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Glycosylated Hemoglobin
The change between 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
Secondary outcomes (26)
Change From Baseline in Fasting Plasma Glucose
The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Fasting Insulin
The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Homeostasis Model Assessment - Insulin Resistance
The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).
Measured: Baseline and Week 24
Median Percent Change From Baseline in High Sensitivity C-reactive Protein
Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100
Measured: Baseline and Week 24
Change From Baseline in Adiponectin
The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Total Cholesterol
The change between 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 Cholesterol
The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in High-Density Lipoprotein Cholesterol
The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Triglycerides
The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Mean Low Density Lipoprotein Particle Concentration
The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Mean Low Density Lipoprotein Particle Size
The change between 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 Large Low Density Lipoprotein (L3) Concentration
The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration
The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Medium-Small Low Density Lipoprotein Concentration
The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Small Low Density Lipoprotein Concentration
The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Very Small Low Density Lipoprotein Concentration
The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Mean High Density Lipoprotein Particle Concentration
The change between 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 Mean High Density Lipoprotein Particle Size
The change between 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 Large High Density Lipoprotein (H4+H5) Concentration
The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration
The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration
The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration
The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Mean Very Low Density Lipoprotein Particle Size
The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.
Measured: Baseline and Week 24
Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration
The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration
The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration
The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- VP Clinical Science Strategy, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727857
- Sponsor's protocol ID
- 01-06-TL-OPIMET-008
- Other IDs
- U1111-1114-0371
- Status last verified
- Jul 2011
- First submitted
- 30 Jul 2008
- Last updated
- 29 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Perez A, Zhao Z, Jacks R, Spanheimer R. Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. Curr Med Res Opin. 2009 Dec;25(12):2915-23. doi: 10.1185/03007990903350011.
PubMed 19827910Perez A, Jacks R, Arora V, Spanheimer R. Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. J Clin Hypertens (Greenwich). 2010 Dec;12(12):973-82. doi: 10.1111/j.1751-7176.2010.00389.x. Epub 2010 Nov 8.
PubMed 21122063
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00727857
- Acronym / sponsor ID
- 01-06-TL-OPIMET-008
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Posted 9 Mar 2010
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 efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
Detailed description
Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism.
Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents.
This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.
Study participation is anticipated to be approximately 6.5 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 15 mg /Metformin 850 mg BID | Experimental | Drug: Pioglitazone and metformin |
| Pioglitazone 15 mg BID | Active comparator | Drug: Pioglitazone |
| Metformin 850 mg BID | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has type 2 diabetes.
- Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.
- A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.
- Body mass index less than or equal to 45 kg/m2.
- Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
Key exclusion criteria (18 listed)
- Type 1 diabetes.
- Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
- History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.
- Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.
- Has a triglyceride level greater than 500 mg per dL.
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 metforminAlso: ACTOPLUS METPioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks. | Drug | Pioglitazone 15 mg /Metformin 850 mg BID |
| PioglitazoneAlso: ACTOS®, AD4833Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks. | Drug | Pioglitazone 15 mg BID |
| MetforminAlso: Fortamet, Glucophage, Glucophage XR, GlumetzaMetformin 850 mg, tablets, orally, twice daily for up to 24 weeks. | Drug | Metformin 850 mg BID |
Primary outcome
Percent Change From Baseline in Glycosylated Hemoglobin
Time frame: Baseline and Week 24
The change between 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.
26 secondary outcomes
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline and Week 24
Change From Baseline in Fasting Insulin
Time frame: Baseline and Week 24
Change From Baseline in Homeostasis Model Assessment - Insulin Resistance
Time frame: Baseline and Week 24
Median Percent Change From Baseline in High Sensitivity C-reactive Protein
Time frame: Baseline and Week 24
Change From Baseline in Adiponectin
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 Cholesterol
Time frame: Baseline and Week 24
Change From Baseline in High-Density Lipoprotein Cholesterol
Time frame: Baseline and Week 24
Change From Baseline in Triglycerides
Time frame: Baseline and Week 24
Change From Baseline in Mean Low Density Lipoprotein Particle Concentration
Time frame: Baseline and Week 24
Change From Baseline in Mean Low Density Lipoprotein Particle Size
Time frame: Baseline and Week 24
Change From Baseline in Large Low Density Lipoprotein (L3) Concentration
Time frame: Baseline and Week 24
Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration
Time frame: Baseline and Week 24
Change From Baseline in Medium-Small Low Density Lipoprotein Concentration
Time frame: Baseline and Week 24
Change From Baseline in Small Low Density Lipoprotein Concentration
Time frame: Baseline and Week 24
Change From Baseline in Very Small Low Density Lipoprotein Concentration
Time frame: Baseline and Week 24
Change From Baseline in Mean High Density Lipoprotein Particle Concentration
Time frame: Baseline and Week 24
Change From Baseline in Mean High Density Lipoprotein Particle Size
Time frame: Baseline and Week 24
Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration
Time frame: Baseline and Week 24
Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration
Time frame: Baseline and Week 24
Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration
Time frame: Baseline and Week 24
Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration
Time frame: Baseline and Week 24
Change From Baseline in Mean Very Low Density Lipoprotein Particle Size
Time frame: Baseline and Week 24
Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration
Time frame: Baseline and Week 24
Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration
Time frame: Baseline and Week 24
Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19827910Perez A, Zhao Z, Jacks R, Spanheimer R. Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. Curr Med Res Opin. 2009 Dec;25(12):2915-23. doi: 10.1185/03007990903350011.
- Results publication: PubMed 21122063Perez A, Jacks R, Arora V, Spanheimer R. Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. J Clin Hypertens (Greenwich). 2010 Dec;12(12):973-82. doi: 10.1111/j.1751-7176.2010.00389.x. Epub 2010 Nov 8.
- ACTOPLUS 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.
VP Clinical Science Strategy study director
Takeda
77 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone and metformin, Pioglitazone and Metformin in people with Diabetes Mellitus, run by Takeda at 77 sites in 4 countries.
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 7 inclusion and 18 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 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Puerto Rico, Chile, Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Glycosylated Hemoglobin (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?
On the ClinicalTrials.gov record for NCT00727857, which also lists 2 linked publications.
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 29 Jul 2011.