Diabetes MellitusPhase 3NCT00707993
Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
A Phase 3 study testing Alogliptin and Glipizide in people with Diabetes Mellitus, run by Takeda at 80 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Alogliptin and Glipizide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 80 sitesin 11 countries
- Study dates
- Jun 2008to Aug 2010
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Has a diagnosis of type 2 diabetes mellitus with either:
- Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
- Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.
Who cannot join
- Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
- Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
- Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
- Calculated creatinine clearance less than or equal to 50 mL/min.
- Thyroid-stimulating hormone level outside of the normal range.
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
Show all 21Show fewer
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
- New York Heart Association Class III or IV heart failure regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with Human Immunodeficiency Virus.
- History of a psychiatric disorder that will affect the participant's ability to participate in the study.
- History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- History of alcohol or substance abuse within the 2 years prior to Screening.
- History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
- Receipt of any investigational drug within the 30 days prior to Screening.
- Prior treatment in an investigational study of alogliptin.
- Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study.
- Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
- Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.
Trial locations and contacts
80 sites in 11 countries.
80 sites in 11 countries
United States36 sites
Study site
Aiken, South Carolina
Study site
Albuquerque, New Mexico
Study site
Alexander City, Alabama
Study site
Aurora, Illinois
Study site
Beachwood, Ohio
Study site
Bensalem, Pennsylvania
Study site
Bradenton, Florida
Study site
Clarkston, Michigan
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Foothill Ranch, California
Study site
Fort Myers, Florida
Study site
Greenville, South Carolina
Study site
Greer, South Carolina
Study site
Hamilton, New Jersey
Study site
Huntington Park, California
Study site
La Porte, Indiana
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Ogden, Utah
Study site
Omaha, Nebraska
Study site
Ormond Beach, Florida
Study site
Pasadena, Texas
Study site
Prospect, Connecticut
Study site
Redlands, California
Study site
Roswell, Georgia
Study site
Salisbury, Maryland
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
South Bend, Indiana
Study site
Taylors, South Carolina
Study site
Tomball, Texas
Study site
Westlake, Ohio
Study site
Winter Park, Florida
Study site
Zanesville, Ohio
Mexico9 sites
Study site
Aguascalientes, Aguascalientes
Study site
Durango, Durango
Study site
Guadalajara
Study site
Mexico City
Study site
Monterrey, Nuevo León
Study site
Morelia, Michoacán
Study site
Nezahualcóyotl
Study site
Pachuca, Hidalgo
Study site
Saltillo, Coahuila
Israel6 sites
Study site
Ashkelon
Study site
Haifa
Study site
Holon
Study site
Nahariya
Study site
Rishon LeZiyyon
Study site
Safed
South Africa6 sites
Study site
Cape Town
Study site
Centurion
Study site
Durban
Study site
Johannesburg
Study site
Port Elizabeth
Study site
Pretoria
Romania5 sites
Study site
Baia Mare
Study site
Brasov
Study site
Bucharest
Study site
Galati
Study site
Satu Mare
India4 sites
Study site
Bangalore, Karnataka
Study site
Belagavi, Karnataka
Study site
Karnāl, Haryana
Study site
Mumbai, Maharashrta
About this study
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.
Read the detailed description
Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and their care is complicated by the extent of their clinical and functional status. Age-related changes in physiology, diabetes-associated illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use problematic. In addition, hypoglycemia is more common and severe in older rather than younger patients taking oral antidiabetic drugs which can precipitate serious events such as falls and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients, many commonly used medications are associated with a substantial risk for hypoglycemia. New classes of drug which avoid such complications in the elderly population are of increasing interest as this population continues to expand.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.
This study will compare the effectiveness and safety of alogliptin with that of glipizide (a commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2 diabetes. Individuals who participate in this study will either have failed diet and exercise therapy alone during the 2 months before Screening, or will have been receiving a single oral antidiabetic medication without obtaining good blood glucose (sugar) control.
Each participant will be required to commit to screening visits. Study participation is anticipated to be up to 59 weeks.
- Conditions
- Diabetes Mellitus
- Being tested
- Alogliptin, Glipizide
- 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, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlogliptinDrug
Also called SYR110322, SYR-322
Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
GlipizideDrug
Also called Glucotrol
Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alogliptin 25 mg QD | Experimental | Not described Receives: Drug: Alogliptin |
| Glipizide 5 mg QD | Active comparator | Not described Receives: Drug: Glipizide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin at Week 52.
The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 52.
Secondary outcomes (18)
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 each week indicated including final visit relative to baseline.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.
Incidence of Hypoglycemia
Percentage of participants with at least one hypoglycemic episode during 52 week study.
Measured: On occurrence (up to 52 weeks).
Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).
The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.
Measured: On Occurrence (up to 52 weeks).
Incidence of Hyperglycemic Rescue
The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.
Measured: On Occurrence (up to 52 weeks).
Change From Baseline in Fasting Plasma Glucose
The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.
Change From Baseline in 2-hour Postprandial Glucose
The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.
Measured: Baseline and Week 52.
Change From Baseline in Fasting Proinsulin
The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.
Measured: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Insulin
The change between the value of insulin collected at each week indicated including final visit relative to baseline.
Measured: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Proinsulin/Insulin Ratio
The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.
Measured: Baseline, Week 12, Week 26, Week 42 and Week 52.
Homeostasis Model Assessment of Beta Cell Function
The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).
Measured: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Body Weight
The change in body weight measured at each week indicated including final visit from baseline.
Measured: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Total Cholesterol)
The change in total cholesterol measured at each week indicated including final visit from baseline.
Measured: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)
The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.
Measured: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)
The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.
Measured: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Triglycerides)
The change in triglycerides measured at each week indicated including final visit from baseline.
Measured: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in High Sensitivity C-reactive Protein
The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.
Measured: Baseline, Week 12, Week 26, Week 42 and Week 52.
Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%
The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.
Measured: Baseline and Week 52.
Incidence of Glycosylated Hemoglobin Decrease From Baseline.
The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.
Measured: Baseline and Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionAug 2010
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.
- 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
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Biological Sciences, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707993
- Sponsor's protocol ID
- SYR-322_303
- Other IDs
- 2008-000959-10, U1111-1112-7905, 2008
- Status last verified
- May 2013
- First submitted
- 27 Jun 2008
- Last updated
- 24 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00707993
- Acronym / sponsor ID
- SYR-322_303
- 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
- 441 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Posted 24 May 2013
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 evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.
Detailed description
Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and their care is complicated by the extent of their clinical and functional status. Age-related changes in physiology, diabetes-associated illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use problematic. In addition, hypoglycemia is more common and severe in older rather than younger patients taking oral antidiabetic drugs which can precipitate serious events such as falls and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients, many commonly used medications are associated with a substantial risk for hypoglycemia. New classes of drug which avoid such complications in the elderly population are of increasing interest as this population continues to expand.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.
This study will compare the effectiveness and safety of alogliptin with that of glipizide (a commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2 diabetes. Individuals who participate in this study will either have failed diet and exercise therapy alone during the 2 months before Screening, or will have been receiving a single oral antidiabetic medication without obtaining good blood glucose (sugar) control.
Each participant will be required to commit to screening visits. Study participation is anticipated to be up to 59 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alogliptin 25 mg QD | Experimental | Drug: Alogliptin |
| Glipizide 5 mg QD | Active comparator | Drug: Glipizide |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Has a diagnosis of type 2 diabetes mellitus with either:
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
Key exclusion criteria (21 listed)
- Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
- Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
- Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
- Calculated creatinine clearance less than or equal to 50 mL/min.
- Thyroid-stimulating hormone level outside of the normal range.
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 |
|---|---|---|
| AlogliptinAlso: SYR110322, SYR-322Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks. | Drug | Alogliptin 25 mg QD |
| GlipizideAlso: GlucotrolAlogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks. | Drug | Glipizide 5 mg QD |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin at Week 52.
Time frame: Baseline and Week 52.
The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
18 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.
Incidence of Hypoglycemia
Time frame: On occurrence (up to 52 weeks).
Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).
Time frame: On Occurrence (up to 52 weeks).
Incidence of Hyperglycemic Rescue
Time frame: On Occurrence (up to 52 weeks).
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.
Change From Baseline in 2-hour Postprandial Glucose
Time frame: Baseline and Week 52.
Change From Baseline in Fasting Proinsulin
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Insulin
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Proinsulin/Insulin Ratio
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Homeostasis Model Assessment of Beta Cell Function
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Body Weight
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Total Cholesterol)
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Triglycerides)
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in High Sensitivity C-reactive Protein
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%
Time frame: Baseline and Week 52.
Incidence of Glycosylated Hemoglobin Decrease From Baseline.
Time frame: Baseline and Week 52.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Biological Sciences study director
Takeda
80 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alogliptin and Glipizide in people with Diabetes Mellitus, run by Takeda at 80 sites in 11 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 8 inclusion and 21 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Mexico, Israel, South Africa, Romania and 6 more countries. 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 24 May 2013). 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?
Change From Baseline in Glycosylated Hemoglobin at Week 52. (time frame: Baseline and Week 52.). 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 24 May 2013.