Diabetes MellitusPhase 2NCT00653185
Efficacy of SYR-472 in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing SYR-472 in people with Diabetes Mellitus, run by Takeda at 87 sites in 12 countries.
Trial summary
The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472, once daily (QD), in subjects with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SYR-472
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 87 sitesin 12 countries
- Study dates
- May 2007to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a historical diagnosis of type 2 diabetes mellitus.
- Has undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
- The subject receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run-in/Stabilization Period as determined by subject diary and investigator assessment.
- Has received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening.
- Has a glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
- The subject's fasting C-peptide concentration is greater than or equal to 0.8 ng/mL.
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- Has a fasting plasma glucose concentration less than 275 mg/dL.
- If regularly uses other non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
- Has a systolic blood pressure reading less than 160 mm Hg and a diastolic pressure reading less than 100 mm Hg.
- Has a hemoglobin value greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
- Has an alanine aminotransferase level is less than or equal to 3 times the upper limit of normal.
- Males have a serum creatinine value less than 1.5 mg/dL; females have a serum creatinine value less than 1.4 mg/dL.
- Has a urine albumin/creatinine ratio less than 1000 μg/mg.
- Has a thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and is clinically euthyroid.
- Females must be not be pregnant or lactating, and must agree to use adequate contraception throughout the duration of the study.
- Is able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
- Has no major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
Who cannot join
- Is being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
- Has a 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.
- Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- Has a history of treated diabetic gastric paresis.
- Has New York Heart Association class III or IV heart failure regardless of therapy.
- Has a history of coronary angioplasty, underwent coronary stent placement or coronary bypass surgery, or suffered a myocardial infarction, or stroke within the 6 months prior to Screening.
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- Has a history of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- Has a history of infection with human immunodeficiency virus.
- Has a history of a psychiatric disorder that in the investigator's opinion will affect the subject's ability to participate in the study.
- Has ingested or received systemically injected glucocorticoids within the 3 months prior to randomization. Inhaled corticosteroids are allowed.
- Has used prescription or over-the-counter weight-loss drugs within the 3 months prior to randomization.
- Has received any investigational drug within the 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
- Has received previous treatment in an investigational study of SYR-472.
- Has a known hypersensitivity to any compound related to SYR-472.
Trial locations and contacts
87 sites in 12 countries.
87 sites in 12 countries
United States51 sites
Study site
Altoona, Pennsylvania
Study site
Ann Arbor, Michigan
Study site
Arlington, Texas
Study site
Bensalem, Ohio
Study site
Birmingham, Alabama
Study site
Brooklyn, New York
Study site
Central Point, Oregon
Study site
Charlotte, North Carolina
Study site
Clearwater, Florida
Study site
Clemson, South Carolina
Study site
Cleveland, Tennessee
Study site
Columbia, South Carolina
Study site
Dawsonville, Georgia
Study site
Dayton, Ohio
Study site
Elkhart, Indiana
Study site
Fargo, North Dakota
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Gainesville, Georgia
Study site
Great Falls, Montana
Study site
Greer, South Carolina
Study site
Hampton, Virginia
Study site
Indianapolis, Indiana
Study site
Kettering, Ohio
Study site
Kingsport, Tennessee
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Mobile, Alabama
Study site
Montgomery, Alabama
Study site
Naperville, Illinois
Study site
National City, California
Study site
North Miami Beach, Florida
Study site
North Richland Hills, Texas
Study site
Ocoee, Florida
Study site
Orlando, Florida
Study site
Pell City, Alabama
Study site
Pismo Beach, California
Study site
Plantation, Florida
Study site
Providence, Rhode Island
Study site
Rapid City, South Dakota
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
Scottsbluff, Nebraska
Study site
Shelby, North Carolina
Study site
Sierra Vista, Arizona
Study site
Slidell, Louisiana
Study site
Sparta, North Carolina
Study site
Spring, Texas
Study site
Sugarland, Texas
Study site
Tallassee, Alabama
Study site
Taunton, Massachusetts
Romania9 sites
Study site
Alba Iulia
Study site
Baia Mare
Study site
Bihor
Study site
Brasov
Study site
Bucharest
Study site
Constanța
Study site
Ploieşti
Study site
Satu Mare
Study site
Targoviste
Russia6 sites
Study site
Kemerovo
Study site
Moscow
Study site
Saint Petersburg
Study site
Ufa
Study site
Volgograd
Study site
Yaroslavl
Lithuania4 sites
Study site
Kaunas
Study site
Kėdainiai
Study site
Klaipėda
Study site
Vilnius
Slovakia3 sites
Study site
Banská Bystrica
Study site
Bratislava
Study site
Prešov
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate Weekly Treatment With SYR-472 in Subjects With Type 2 Diabetes
The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472, once daily (QD), in subjects with Type 2 Diabetes Mellitus.
Read the detailed description
Type 2 diabetes mellitus is a complex metabolic disorder characterized by abnormal insulin secretion and glucose homeostasis, resulting from impaired pancreatic beta-cell function and insulin resistance in target tissues. The worldwide prevalence of type 2 diabetes mellitus is reaching epidemic proportions, and the total number of cases is expected to reach 221 million by 2010. The high incidence of the disease and its associated complications places a significant burden on healthcare systems.
The primary risk factor for the development of type 2 diabetes mellitus is obesity and its associated insulin resistance. Insulin resistance is characterized by an impaired response to the physiologic effects of insulin and leads to decreased cellular glucose uptake, increased hepatic gluconeogenesis, and a compensatory increase in insulin secretion that contributes to beta-cell exhaustion. Therefore in the insulin-resistant state, blood glucose and insulin levels are increased. The relationship between improved glycemic control in patients with type 2 diabetes mellitus and the delay or prevention of comorbidities has been reported in the Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study. Therefore, reduction of persistent hyperglycemia is the highest priority in treating this disease.
Diet and exercise are important and effective measures for maintaining glycemic control in individuals with insulin resistance, impaired glucose tolerance, and type 2 diabetes mellitus, particularly in the early stages of disease progression. In cases where diet and exercise alone fail to adequately maintain glycemic control, oral antidiabetic drugs are typically used. Combination oral therapy and eventually insulin are usually required to maintain lower blood glucose levels but can result in adverse effects including hypoglycemia and weight gain. Therefore, novel safe and effective antidiabetic therapies are needed.
Dipeptidyl peptidase-4 is a ubiquitous aminopeptidase that is widely expressed in many tissues; it is thought to be primarily responsible for the in vivo degradation of at least two gut-derived incretin hormones, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide, which are both released in response to nutrient ingestion. Glucagon-like peptide-1 has been demonstrated to augment glucose-dependent insulin secretion; suppress glucagon release and hepatic gluconeogenesis; inhibit gastric emptying, and reduce appetite and food intake. Glucagon-like peptide-1 and glucose-dependent insulinotropic peptide also have been shown to promote insulin biosynthesis and stimulate beta cell proliferation and survival. Orally available inhibitors of dipeptidyl peptidase-4 activity have been developed that increase intact postprandial glucagon-like peptide-1 levels after oral administration.
SYR-472 is a selective inhibitor of dipeptidyl peptidase-4 in development to improve glycemic control in patients with type 2 diabetes mellitus. The aim of this study is to evaluate SYR-472 in subjects with type 2 diabetes mellitus who have not previously achieved adequate glycemic control with lifestyle modification (diet/exercise) or metformin antidiabetic monotherapy. Study participation is anticipated to be up to 14 weeks.
- Conditions
- Diabetes Mellitus
- Being tested
- SYR-472, Placebo
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYR-472Drug
SYR-472 25 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
SYR-472Drug
SYR-472 50 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
SYR-472Drug
SYR-472 100 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
SYR-472Drug
SYR-472 200 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
PlaceboDrug
SYR-472 placebo-matching tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYR-472 25 mg QD | Experimental | (with lifestyle modification and/or metformin therapy) Receives: Drug: SYR-472 |
| SYR-472 50 mg QD | Experimental | (with lifestyle modification and/or metformin therapy) Receives: Drug: SYR-472 |
| SYR-472 100 mg QD | Experimental | (with lifestyle modification and/or metformin therapy) Receives: Drug: SYR-472 |
| SYR-472 200 mg QD | Experimental | (with lifestyle modification and/or metformin therapy) Receives: Drug: SYR-472 |
| Placebo QD | Placebo comparator | (with lifestyle modification and/or metformin therapy) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycosylated hemoglobin
Measured: Weeks 12 or Final Visit.
Secondary outcomes (14)
Change from baseline in glycosylated hemoglobin
Measured: Weeks 4, 8, and 12 or Final Visit.
Change from baseline in fasting plasma glucose
Measured: Weeks 1, 2, 4, 8, and 12 or Final Visit.
1,5-Anhydroglucitol
Measured: Weeks 2, 4, 8, and 12 or Final Visit.
Change in Proinsulin
Measured: Weeks 4, 8, and 12 or Final Visit.
Change in Proinsulin/insulin ratio
Measured: Weeks 4, 8, and 12 or Final Visit.
Change in baseline C-peptide
Measured: Weeks 4, 8, and 12 or Final Visit.
Change from baseline in insulin
Measured: Weeks 4, 8, and 12 or Final Visit.
Change in Homeostasis model assessment of beta cell function
Measured: Weeks 4, 8, and 12 or Final Visit.
Change in Homeostasis model assessment of insulin resistance
Measured: Weeks 4, 8, and 12 or Final Visit
Incidence of rescue
Measured: Weeks 1, 2, 4, 8, and 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin less than or equal to 6.5%
Measured: Week 12 or Final Visit
Clinical response endpoint incidence of glycosylated hemoglobin less than or equal to 7.0%
Measured: Week 12 or Final Visit
Change from baseline in Fasting lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol)
Measured: Weeks 4, 8, and 12 or Final Visit
Body weight
Measured: Weeks 4, 8, and 12 or Final Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653185
- Sponsor's protocol ID
- 01-06-TL-SYR-472-007
- Other IDs
- U1111-1183-0302
- Status last verified
- Jun 2016
- First submitted
- 1 Apr 2008
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate Weekly Treatment With SYR-472 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00653185
- Acronym / sponsor ID
- 01-06-TL-SYR-472-007
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Hyperglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 Apr 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 efficacy, safety and tolerability of SYR-472, once daily (QD), in subjects with Type 2 Diabetes Mellitus.
Detailed description
Type 2 diabetes mellitus is a complex metabolic disorder characterized by abnormal insulin secretion and glucose homeostasis, resulting from impaired pancreatic beta-cell function and insulin resistance in target tissues. The worldwide prevalence of type 2 diabetes mellitus is reaching epidemic proportions, and the total number of cases is expected to reach 221 million by 2010. The high incidence of the disease and its associated complications places a significant burden on healthcare systems.
The primary risk factor for the development of type 2 diabetes mellitus is obesity and its associated insulin resistance. Insulin resistance is characterized by an impaired response to the physiologic effects of insulin and leads to decreased cellular glucose uptake, increased hepatic gluconeogenesis, and a compensatory increase in insulin secretion that contributes to beta-cell exhaustion. Therefore in the insulin-resistant state, blood glucose and insulin levels are increased. The relationship between improved glycemic control in patients with type 2 diabetes mellitus and the delay or prevention of comorbidities has been reported in the Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study. Therefore, reduction of persistent hyperglycemia is the highest priority in treating this disease.
Diet and exercise are important and effective measures for maintaining glycemic control in individuals with insulin resistance, impaired glucose tolerance, and type 2 diabetes mellitus, particularly in the early stages of disease progression. In cases where diet and exercise alone fail to adequately maintain glycemic control, oral antidiabetic drugs are typically used. Combination oral therapy and eventually insulin are usually required to maintain lower blood glucose levels but can result in adverse effects including hypoglycemia and weight gain. Therefore, novel safe and effective antidiabetic therapies are needed.
Dipeptidyl peptidase-4 is a ubiquitous aminopeptidase that is widely expressed in many tissues; it is thought to be primarily responsible for the in vivo degradation of at least two gut-derived incretin hormones, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide, which are both released in response to nutrient ingestion. Glucagon-like peptide-1 has been demonstrated to augment glucose-dependent insulin secretion; suppress glucagon release and hepatic gluconeogenesis; inhibit gastric emptying, and reduce appetite and food intake. Glucagon-like peptide-1 and glucose-dependent insulinotropic peptide also have been shown to promote insulin biosynthesis and stimulate beta cell proliferation and survival. Orally available inhibitors of dipeptidyl peptidase-4 activity have been developed that increase intact postprandial glucagon-like peptide-1 levels after oral administration.
SYR-472 is a selective inhibitor of dipeptidyl peptidase-4 in development to improve glycemic control in patients with type 2 diabetes mellitus. The aim of this study is to evaluate SYR-472 in subjects with type 2 diabetes mellitus who have not previously achieved adequate glycemic control with lifestyle modification (diet/exercise) or metformin antidiabetic monotherapy. Study participation is anticipated to be up to 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SYR-472 25 mg QD | Experimental | Drug: SYR-472(with lifestyle modification and/or metformin therapy) |
| SYR-472 50 mg QD | Experimental | Drug: SYR-472(with lifestyle modification and/or metformin therapy) |
| SYR-472 100 mg QD | Experimental | Drug: SYR-472(with lifestyle modification and/or metformin therapy) |
| SYR-472 200 mg QD | Experimental | Drug: SYR-472(with lifestyle modification and/or metformin therapy) |
| Placebo QD | Placebo comparator | Drug: Placebo(with lifestyle modification and/or metformin therapy) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Has a historical diagnosis of type 2 diabetes mellitus.
- Has undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
- The subject receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run-in/Stabilization Period as determined by subject diary and investigator assessment.
- Has received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening.
- Has a glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
Key exclusion criteria (14 listed)
- Is being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
- Has a 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.
- Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- Has a history of treated diabetic gastric paresis.
- Has New York Heart Association class III or IV heart failure regardless of therapy.
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 |
|---|---|---|
| SYR-472SYR-472 25 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks. | Drug | SYR-472 25 mg QD |
| SYR-472SYR-472 50 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks. | Drug | SYR-472 50 mg QD |
| SYR-472SYR-472 100 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks. | Drug | SYR-472 100 mg QD |
| SYR-472SYR-472 200 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks. | Drug | SYR-472 200 mg QD |
| PlaceboSYR-472 placebo-matching tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks. | Drug | Placebo QD |
Primary outcome
Change from baseline in glycosylated hemoglobin
Time frame: Weeks 12 or Final Visit.
14 secondary outcomes
Change from baseline in glycosylated hemoglobin
Time frame: Weeks 4, 8, and 12 or Final Visit.
Change from baseline in fasting plasma glucose
Time frame: Weeks 1, 2, 4, 8, and 12 or Final Visit.
1,5-Anhydroglucitol
Time frame: Weeks 2, 4, 8, and 12 or Final Visit.
Change in Proinsulin
Time frame: Weeks 4, 8, and 12 or Final Visit.
Change in Proinsulin/insulin ratio
Time frame: Weeks 4, 8, and 12 or Final Visit.
Change in baseline C-peptide
Time frame: Weeks 4, 8, and 12 or Final Visit.
Change from baseline in insulin
Time frame: Weeks 4, 8, and 12 or Final Visit.
Change in Homeostasis model assessment of beta cell function
Time frame: Weeks 4, 8, and 12 or Final Visit.
Change in Homeostasis model assessment of insulin resistance
Time frame: Weeks 4, 8, and 12 or Final Visit
Incidence of rescue
Time frame: Weeks 1, 2, 4, 8, and 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin less than or equal to 6.5%
Time frame: Week 12 or Final Visit
Clinical response endpoint incidence of glycosylated hemoglobin less than or equal to 7.0%
Time frame: Week 12 or Final Visit
Change from baseline in Fasting lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol)
Time frame: Weeks 4, 8, and 12 or Final Visit
Body weight
Time frame: Weeks 4, 8, and 12 or Final Visit.
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 22 Jun 2016.
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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
87 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYR-472 in people with Diabetes Mellitus, run by Takeda at 87 sites in 12 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 17 inclusion and 14 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 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Romania, Russia, Lithuania, Latvia and 7 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glycosylated hemoglobin (time frame: Weeks 12 or Final Visit.). 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 22 Jun 2016.