Diabetes MellitusPhase 3NCT00286468
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
A Phase 3 study testing Alogliptin and glyburide and Glyburide in people with Diabetes Mellitus, run by Takeda at 68 sites in 15 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults 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?
- Alogliptin and glyburide and Glyburide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 68 sitesin 15 countries
- Study dates
- Apr 2006to Jun 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus , currently treated with a sulfonylurea alone but experiencing inadequate glycemic control. Should have received the sulfonylurea monotherapy for at least the 3 months prior to Screening; has been on a stable sulfonylurea dose equivalent to at least 10 mg of glyburide (Exception: documented maximum tolerated dose equivalent to less than 10 mg but at least 5 mg glyburide) for at least 8 weeks.
- No treatment with antidiabetic agents other than a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- Fasting C-peptide concentration greater than or equal to 0.8 ng/mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng/mL after a challenge test.).
- Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.
- If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
Show all 16Show fewer
- Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
- Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females
- Alanine aminotransferase less than or equal to 3 time the upper limit of normal.
- Serum creatinine ≤2.0 mg/dL (≤17 micromol/L)
- Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
- Neither pregnant nor lactating
- Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in 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 subject from completing the study.
- Able and willing to provide written informed consent
Who cannot join
- Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
- 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. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastric paresis.
- New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
Show all 17Show fewer
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- History of a psychiatric disorder that will affect the subject'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.
- Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
- Prior treatment in an investigational study of alogliptin.
- Excluded Medications and Treatments:
- Treatment with antidiabetic agents other than study drug or glyburide is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.
- Treatment with weight-loss drugs, any investigational antidiabetics, Bosentan (used for the treatment of pulmonary hypertension), or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of- treatment/early termination procedures. Inhaled corticosteroids are allowed.
- Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator.
Trial locations and contacts
68 sites in 15 countries.
68 sites in 15 countries
United States54 sites
Study site
Anaheim, California
Study site
Artesia, California
Study site
Avon, Indiana
Study site
Baltimore, Maryland
Study site
Berlin, New Jersey
Study site
Birmingham, Alabama
Study site
Burlington, North Carolina
Study site
Burlington, Vermont
Study site
Charleston, South Carolina
Study site
Cincinnati, Ohio
Study site
Cocoa Beach, Florida
Study site
Columbia, South Carolina
Study site
Cookeville, Tennessee
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Dayton, Ohio
Study site
Denver, Colorado
Study site
Erlanger, Kentucky
Study site
Evansville, Indiana
Study site
Fresno, California
Study site
Honolulu, Hawaii
Study site
Idaho Falls, Idaho
Study site
Kissimmee, Florida
Study site
Lafayette, Indiana
Study site
Lansdale, Pennsylvania
Study site
Lawrenceville, Georgia
Study site
Longwood, Florida
Study site
Los Angeles, California
Study site
Milan, Tennessee
Study site
Mission Viejo, California
Study site
Morehead City, North Carolina
Study site
New Port Richey, Florida
Study site
Northridge, California
Study site
Ocala, Florida
Study site
Ocoee, Florida
Study site
Omaha, Nebraska
Study site
Orange, California
Study site
Peoria, Arizona
Study site
Phoenix, Arizona
Study site
Pinehurst, North Carolina
Study site
Saint Cloud, Florida
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Simpsonville, South Carolina
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Temple, Texas
Study site
Texarkana, Texas
Study site
Tulsa, Oklahoma
Study site
Tustin, California
Study site
Walnut Creek, California
Study site
Washington D.C., District of Columbia
Study site
West Grove, Pennsylvania
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
Read the detailed description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.
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.
The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).
- Conditions
- Diabetes Mellitus
- Being tested
- Alogliptin and glyburide, Glyburide
- 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.
Alogliptin and glyburideDrug
Also called alogliptin, SYR110322, SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
Alogliptin and glyburideDrug
Also called alogliptin, SYR110322, SYR-322
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
GlyburideDrug
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alogliptin 12.5 mg QD | Experimental | Not described Receives: Drug: Alogliptin and glyburide |
| Alogliptin 25 mg QD | Experimental | Not described Receives: Drug: Alogliptin and glyburide |
| Placebo | Active comparator | Not described Receives: Drug: Glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
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 week 26 or final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 26.
Secondary outcomes (50)
Change From Baseline in Glycosylated Hemoglobin (Week 4).
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 week 4 and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Glycosylated Hemoglobin (Week 8).
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 week 8 and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
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 week 12 and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
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 week 16 and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
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 week 20 and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 1).
The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 1.
Change From Baseline in Fasting Plasma Glucose (Week 2).
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 2.
Change From Baseline in Fasting Plasma Glucose (Week 4).
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 8).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting Plasma Glucose (Week 16).
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Fasting Plasma Glucose (Week 20).
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 26).
The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 26.
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.
Measured: 26 Weeks.
Number of Participants Requiring Rescue.
The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
Measured: 26 Weeks.
Change From Baseline in Fasting Proinsulin (Week 4).
The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Fasting Proinsulin (Week 8).
The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Proinsulin (Week 12).
The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting Proinsulin (Week 16).
The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Fasting Proinsulin (Week 20).
The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting Proinsulin (Week 26).
The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.
Measured: Baseline and Week 26.
Change From Baseline in Insulin (Week 4).
The change between the value of insulin collected at week 4 and insulin collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Insulin (Week 8).
The change between the value of insulin collected at week 8 and insulin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Insulin (Week 12).
The change between the value of insulin collected at week 12 and insulin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Insulin (Week 16).
The change between the value of insulin collected at week 16 and insulin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Insulin (Week 20).
The change between the value of insulin collected at week 20 and insulin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Insulin (Week 26).
The change between the value of insulin collected at week 26 and insulin collected at baseline.
Measured: Baseline and Week 26.
Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.
Measured: Baseline and Week 26.
Change From Baseline in C-peptide (Week 4).
The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in C-peptide (Week 8).
The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in C-peptide (Week 12).
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in C-peptide (Week 16).
The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in C-peptide (Week 20).
The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in C-peptide (Week 26).
The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.
The number 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% during the 26 week study.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.
The number 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 1.0% during the 26 week study.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.
The number 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 1.5% during the 26 week study.
Measured: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.
The number 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 2.0% during the 26 week study.
Measured: Baseline and Week 26.
Change From Baseline in Body Weight (Week 8).
The change between Body Weight measured at week 8 and Body Weight measured at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Body Weight (Week 12).
The change between Body Weight measured at week 12 and Body Weight measured at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Body Weight (Week 20).
The change between Body Weight measured at week 20 and Body Weight measured at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Body Weight (Week 26).
The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.
Measured: Baseline and Week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- 500 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
- NCT00286468
- Sponsor's protocol ID
- SYR-322-SULF-007
- Other IDs
- 2005-004667-36, U1111-1113-8506, 2005
- Status last verified
- Feb 2012
- First submitted
- 1 Feb 2006
- Last updated
- 3 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab. 2009 Feb;11(2):167-76. doi: 10.1111/j.1463-1326.2008.01016.x.
PubMed 19125778Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.
PubMed 19793357
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00286468
- Acronym / sponsor ID
- SYR-322-SULF-007
- 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
- 500 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Posted 25 Aug 2011
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), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
Detailed description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.
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.
The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 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 |
|---|---|---|
| Alogliptin 12.5 mg QD | Experimental | Drug: Alogliptin and glyburide |
| Alogliptin 25 mg QD | Experimental | Drug: Alogliptin and glyburide |
| Placebo | Active comparator | Drug: Glyburide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of type 2 diabetes mellitus , currently treated with a sulfonylurea alone but experiencing inadequate glycemic control. Should have received the sulfonylurea monotherapy for at least the 3 months prior to Screening; has been on a stable sulfonylurea dose equivalent to at least 10 mg of glyburide (Exception: documented maximum tolerated dose equivalent to less than 10 mg but at least 5 mg glyburide) for at least 8 weeks.
- No treatment with antidiabetic agents other than a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
- Fasting C-peptide concentration greater than or equal to 0.8 ng/mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng/mL after a challenge test.).
- Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.
Key exclusion criteria (17 listed)
- Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
- 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. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastric paresis.
- New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
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 |
|---|---|---|
| Alogliptin and glyburideAlso: alogliptin, SYR110322, SYR-322Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. | Drug | Alogliptin 12.5 mg QD |
| Alogliptin and glyburideAlso: alogliptin, SYR110322, SYR-322Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks. | Drug | Alogliptin 25 mg QD |
| GlyburideAlogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
Time frame: Baseline and Week 26.
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 week 26 or final visit and glycosylated hemoglobin collected at baseline.
50 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 1).
Time frame: Baseline and Week 1.
Change From Baseline in Fasting Plasma Glucose (Week 2).
Time frame: Baseline and Week 2.
Change From Baseline in Fasting Plasma Glucose (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting Plasma Glucose (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Fasting Plasma Glucose (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 26).
Time frame: Baseline and Week 26.
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
Time frame: 26 Weeks.
Number of Participants Requiring Rescue.
Time frame: 26 Weeks.
Change From Baseline in Fasting Proinsulin (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Fasting Proinsulin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Proinsulin (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting Proinsulin (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Fasting Proinsulin (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Proinsulin (Week 26).
Time frame: Baseline and Week 26.
Change From Baseline in Insulin (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Insulin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Insulin (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Insulin (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Insulin (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Insulin (Week 26).
Time frame: Baseline and Week 26.
Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
Time frame: Baseline and Week 26.
Change From Baseline in C-peptide (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in C-peptide (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in C-peptide (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in C-peptide (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in C-peptide (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in C-peptide (Week 26).
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
Time frame: Baseline and Week 26.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19125778Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab. 2009 Feb;11(2):167-76. doi: 10.1111/j.1463-1326.2008.01016.x.
- Results publication: PubMed 19793357Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.
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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
68 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alogliptin and glyburide and Glyburide in people with Diabetes Mellitus, run by Takeda at 68 sites in 15 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 16 inclusion and 17 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 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Argentina, Australia, Brazil, Chile and 10 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 25 Aug 2011). 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 (HbA1c) at Week 26. (time frame: Baseline and Week 26.). 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 NCT00286468, 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 3 Feb 2012.