Diabetes Mellitus, Type IIPhase 2NCT00642278
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
A Phase 2 study testing Canagliflozin (JNJ-28431754) and Sitagliptin in people with Diabetes Mellitus, Type II and Diabetes Mellitus, Non Insulin Dependent, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 78 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type II, Diabetes Mellitus, Non Insulin Dependent
- What is being tested?
- Canagliflozin (JNJ-28431754) and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 451 participants
- Where
- 78 sitesin 13 countries
- Study dates
- Apr 2008to Jan 2009
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c levels >=7% and <=10.5%
- taking a stable daily dose of metformin
- Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
- Stable body weight
- Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women
Who cannot join
- Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
- Known contraindication or suspected hypersensitivity to sitagliptin or metformin
- A history of diabetic ketoacidosis or type 1 diabetes mellitus
- History of pancreas or beta-cell transplantation
- History of active proliferative diabetic retinopathy
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Trial locations and contacts
78 sites in 13 countries.
78 sites in 13 countries
United States30 sites
Study site
Albuquerque, New Mexico
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Cherry Hill, New Jersey
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Encinitas, California
Study site
Golden, Colorado
Study site
Greer, South Carolina
Study site
Haverhill, Massachusetts
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Lincoln, California
Study site
Los Angeles, California
Study site
Merced, California
Study site
Mesa, Arizona
Study site
Milwaukee, Wisconsin
Study site
Nampa, Idaho
Study site
New Braunfels, Texas
Study site
New Hyde Park, New York
Study site
Odessa, Texas
Study site
Oklahoma City, Oklahoma
Study site
Portland, Oregon
Study site
Roseville, California
Study site
Salisbury, North Carolina
Study site
San Antonio, Texas
Study site
Topeka, Kansas
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Canada8 sites
Study site
Brampton, Ontario
Study site
Chilliwack, British Columbia
Study site
Coquitlam, British Columbia
Study site
Pointe-Claire, Quebec
Study site
Saint Romuald, Quebec
Study site
Sarnia, Ontario
Study site
Saskatoon, Saskatchewan
Study site
Toronto, Ontario
Poland8 sites
Study site
Bydgoszcz
Study site
Gdansk
Study site
Kutno
Study site
Lodz
Study site
Lublin
Study site
Torun
Study site
Warsaw
Study site
Wroclaw
Romania6 sites
Study site
Baia Mare
Study site
Brasov
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Galati
Study site
Ploieşti
India4 sites
Study site
Bangalore
Study site
Hyderabad
Study site
Nagpur
Study site
Pune
Mexico4 sites
Study site
México
Study site
Mexico City
Study site
Monterrey
Study site
Zapopan
United Kingdom4 sites
Study site
Belfast
Study site
Bolton
Study site
Exeter
Study site
Lincoln
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
Read the detailed description
Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).
- Being tested
- Canagliflozin (JNJ-28431754), Sitagliptin, Placebo
- Keywords
- Type 2 diabetes mellitus, Metformin, Hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin (JNJ-28431754)Drug
Also called JNJ-28431754
One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.
SitagliptinDrug
One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
PlaceboDrug
One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin 50 mg daily | Experimental | Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo |
| Canagliflozin 100 mg daily | Experimental | Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo |
| Canagliflozin 200 mg daily | Experimental | Each patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo |
| Canagliflozin 300 mg daily | Experimental | Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening). Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo |
| Canagliflozin 300 mg twice daily | Experimental | Each patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks. Receives: Drug: Canagliflozin (JNJ-28431754) |
| Sitagliptin 100 mg daily | Active comparator | Each patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). Receives: Drug: Sitagliptin; Drug: Placebo |
| Placebo | Placebo comparator | Each patient will receive matching placebo twice daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline to Week 12
The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Secondary outcomes (5)
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12
The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Percentage of Patients With Symptoms of Hypoglycemia
The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.
Measured: Up to Week 12
Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12
The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Absolute Change in Body Weight From Baseline to Week 12
The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.
Measured: Day 1 (Baseline) and Week 12
Percent Change in Body Weight From Baseline to Week 12
The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
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 (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- 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
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642278
- Sponsor's protocol ID
- CR014587
- Other IDs
- 28431754DIA2001
- Status last verified
- Jul 2013
- First submitted
- 21 Mar 2008
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nyirjesy P, Zhao Y, Ways K, Usiskin K. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor. Curr Med Res Opin. 2012 Jul;28(7):1173-8. doi: 10.1185/03007995.2012.697053. Epub 2012 Jun 14.
PubMed 22632452Nicolle LE, Capuano G, Ways K, Usiskin K. Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. Curr Med Res Opin. 2012 Jul;28(7):1167-71. doi: 10.1185/03007995.2012.689956. Epub 2012 May 15.
PubMed 22548646Rosenstock J, Aggarwal N, Polidori D, Zhao Y, Arbit D, Usiskin K, Capuano G, Canovatchel W; Canagliflozin DIA 2001 Study Group. Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. Diabetes Care. 2012 Jun;35(6):1232-8. doi: 10.2337/dc11-1926. Epub 2012 Apr 9.
PubMed 22492586
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm
- ClinicalTrials.gov ID
- NCT00642278
- Acronym / sponsor ID
- CR014587
- Keywords
- Type 2 diabetes mellitus, Metformin, Hemoglobin A1c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 17 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 effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
Detailed description
Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Canagliflozin 50 mg daily | Experimental | Drug: Canagliflozin (JNJ-28431754), Drug: PlaceboEach patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). |
| Canagliflozin 100 mg daily | Experimental | Drug: Canagliflozin (JNJ-28431754), Drug: PlaceboEach patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). |
| Canagliflozin 200 mg daily | Experimental | Drug: Canagliflozin (JNJ-28431754), Drug: PlaceboEach patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). |
| Canagliflozin 300 mg daily | Experimental | Drug: Canagliflozin (JNJ-28431754), Drug: PlaceboEach patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening). |
| Canagliflozin 300 mg twice daily | Experimental | Drug: Canagliflozin (JNJ-28431754)Each patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks. |
| Sitagliptin 100 mg daily | Active comparator | Drug: Sitagliptin, Drug: PlaceboEach patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). |
| Placebo | Placebo comparator | Drug: PlaceboEach patient will receive matching placebo twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have a diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c levels >=7% and <=10.5%
- taking a stable daily dose of metformin
- Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
- Stable body weight
Key exclusion criteria (6 listed)
- Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
- Known contraindication or suspected hypersensitivity to sitagliptin or metformin
- A history of diabetic ketoacidosis or type 1 diabetes mellitus
- History of pancreas or beta-cell transplantation
- History of active proliferative diabetic retinopathy
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 |
|---|---|---|
| Canagliflozin (JNJ-28431754)Also: JNJ-28431754One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks. | Drug | Canagliflozin 100 mg daily, Canagliflozin 200 mg daily, Canagliflozin 300 mg daily, Canagliflozin 300 mg twice daily, Canagliflozin 50 mg daily |
| SitagliptinOne 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. | Drug | Sitagliptin 100 mg daily |
| PlaceboOne matching placebo capsule orally (by mouth) once or twice daily for 12 weeks. | Drug | Canagliflozin 100 mg daily, Canagliflozin 200 mg daily, Canagliflozin 300 mg daily, Canagliflozin 50 mg daily, Placebo, Sitagliptin 100 mg daily |
Primary outcome
Change in HbA1c From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
5 secondary outcomes
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Percentage of Patients With Symptoms of Hypoglycemia
Time frame: Up to Week 12
Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Absolute Change in Body Weight From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Percent Change in Body Weight From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22632452Nyirjesy P, Zhao Y, Ways K, Usiskin K. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor. Curr Med Res Opin. 2012 Jul;28(7):1173-8. doi: 10.1185/03007995.2012.697053. Epub 2012 Jun 14.
- Derived from this study: PubMed 22548646Nicolle LE, Capuano G, Ways K, Usiskin K. Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. Curr Med Res Opin. 2012 Jul;28(7):1167-71. doi: 10.1185/03007995.2012.689956. Epub 2012 May 15.
- Derived from this study: PubMed 22492586Rosenstock J, Aggarwal N, Polidori D, Zhao Y, Arbit D, Usiskin K, Capuano G, Canovatchel W; Canagliflozin DIA 2001 Study Group. Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. Diabetes Care. 2012 Jun;35(6):1232-8. doi: 10.2337/dc11-1926. Epub 2012 Apr 9.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
78 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canagliflozin (JNJ-28431754) and Sitagliptin in people with Diabetes Mellitus, Type II and Diabetes Mellitus, Non Insulin Dependent, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 78 sites in 13 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 6 inclusion and 6 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Canada, Poland, Romania, India and 8 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?
Yes. Results are posted in the registry (first posted 17 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 in HbA1c From Baseline to Week 12 (time frame: Day 1 (Baseline) and Week 12). 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 NCT00642278, which also lists 3 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 19 Jul 2013.