Type 2 Diabetes MellitusPhase 3NCT00641056

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

A Phase 3 study testing Exenatide Once Weekly and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 75 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Exenatide Once Weekly and Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 467 participants
Where: 75 sitesin 16 countries
Study dates: Apr 2008to Nov 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has type 2 diabetes and at least 18 years of age at screening.
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.

Who cannot join

Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
Have a history of renal transplantation or are currently receiving renal dialysis.
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.
Have any contraindication for the oral antidiabetic agent which they use.

Show all 22Show fewer

Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
Are known to have active proliferative retinopathy.
Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
Insulin
Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])
Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])
Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).
Byetta® (exenatide BID formulation)
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin])
Symlin® (pramlintide acetate).
Have had an organ transplant.
Have donated blood within 30 days of screening.
Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Are currently enrolled in any other clinical study.

Trial locations and contacts

75 sites in 16 countries.

Country

City, postcode or hospital

75 sites in 16 countries

United States12 sites

Research Site
Ada, Oklahoma
Research Site
Dayton, Ohio
Research Site
Escondido, California
Research Site
Honolulu, Hawaii
Research Site
Idaho Falls, Idaho
Research Site
Jacksonville, Florida
Research Site
Minneapolis, Minnesota
Research Site
Orlando, Florida
Research Site
San Antonio, Texas
Research Site
Spokane, Washington
Research Site
St Louis, Missouri
Research Site
West Palm Beach, Florida

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Germany9 sites

Research Site
Bad Mergentheim
Research Site
Dresden
Research Site
Essen
Research Site
Falkensee
Research Site
Fulda
Research Site
Münster
Research Site
Othmarschen
Research Site
Rothenburg An Der Fulda
Research Site
Speyer

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Spain7 sites

Research Site
Alicante
Research Site
Alzira-Valencia
Research Site
Barcelona
Research Site
Bilbao
Research Site
Madrid
Research Site
Málaga
Research Site
Teruel

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Australia6 sites

Research Site
Adelaide, South Australia
Research Site
Box Hill, Victoria
Research Site
Geelong, Victoria
Research Site
Herston, Queensland
Research Site
Keswick, South Australia
Research Site
Wollongong, New South Wales

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Netherlands6 sites

Research Site
Amsterdam
Research Site
Gouda
Research Site
Hoogeveen
Research Site
Rotterdam
Research Site
Zwijndrecht
Research Site
Zwolle

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France5 sites

Research Site
Angers
Research Site
Corbeil Essoness
Research Site
Nancy
Research Site
Nanterre
Research Site
Toulouse

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Denmark4 sites

Research Site
Aalborg
Research Site
Arhus C
Research Site
Herlev
Research Site
Køge

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Hungary4 sites

Research Site
Budapest
Research Site
Eger
Research Site
Gyula
Research Site
Pécs

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Mexico4 sites

Research Site
Mérida
Research Site
Mexico City
Research Site
Tampico
Research Site
Tijuana

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Taiwan4 sites

Research Site
Chiayi City
Research Site
Tainan County
Research Site
Taipei
Research Site
Taoyuan

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Czechia3 sites

Research Site
Mělník
Research Site
Prague
Research Site
Stodůlky

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Russia3 sites

Research Site
Moscow
Research Site
Rostov-on-Don
Research Site
Saint Petersburg

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Belgium2 sites

Research Site
Brussels
Research Site
Edegem

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Greece2 sites

Research Site
Athens
Research Site
Thessaloniki

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Puerto Rico2 sites

Research Site
Caguas
Research Site
Yabucoa

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South Korea2 sites

Research Site
Gyeonggi-do
Research Site
Seoul

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About this study

Official title: Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

Conditions: Type 2 Diabetes Mellitus
Being tested: Exenatide Once Weekly, Insulin Glargine
Keywords: diabetes, exenatide, exenatide once weekly, metformin, sulfonylurea, insulin glargine, Amylin, Lilly
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exenatide Once WeeklyDrug
subcutaneous injection, 2.0mcg, once weekly
Insulin GlargineDrug
subcutaneous injection, variable dose, QD

Study groups in NCT00641056
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Exenatide Once Weekly
2	Active comparator	Not described Receives: Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to Week 26
Measured: Baseline, Week 26

Secondary outcomes (9)

Percentage of Patients Achieving HbA1c <=7.0% at Week 26
Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)
Measured: Baseline, Week 26
Percentage of Patients Achieving HbA1c <=6.5% at Week 26
Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)
Measured: Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Change in FSG (mmol/L) from Baseline to Week 26
Measured: Baseline, Week 26
Change in Body Weight (BW) From Baseline to Week 26
Change in BW (kg) from Baseline to Week 26
Measured: Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Change in Total Cholesterol (mmol/L) from Baseline to Week 26
Measured: Baseline, Week 26
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26
Change in HDL (mmol/L) from Baseline to Week 26
Measured: Baseline, Week 26
Ratio of Triglycerides at Week 26 to Baseline
Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Measured: Baseline, Week 26
Change in Blood Pressure From Baseline to Week 26
Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26
Measured: Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.
Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Nov 2009

First posted21 Mar 2008 (estimated)
Study startApr 2008
Primary completionMay 2009
Study completionNov 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 (7)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: None (open label)
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00641056
Sponsor's protocol ID: H8O-MC-GWBR (DURATION - 3)
Status last verified: May 2015
First submitted: 17 Mar 2008
Last updated: 15 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22.
PubMed 22357185
Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
PubMed 32306296
Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4.
PubMed 24731672
Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
PubMed 23748506
Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
PubMed 23522121
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PubMed 22236356
Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.
PubMed 20609969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea
ClinicalTrials.gov ID: NCT00641056
Acronym / sponsor ID: H8O-MC-GWBR (DURATION - 3)
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, exenatide, exenatide once weekly, metformin, sulfonylurea, insulin glargine, Amylin, Lilly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Apr 2008
Primary completion: May 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 21 Mar 2008 (estimated)
Results: Posted 4 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Exenatide Once Weekly
2	Active comparator	Drug: Insulin Glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Has type 2 diabetes and at least 18 years of age at screening.
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR

Key exclusion criteria (22 listed)

Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
Have a history of renal transplantation or are currently receiving renal dialysis.
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.

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
Exenatide Once Weeklysubcutaneous injection, 2.0mcg, once weekly	Drug	1
Insulin Glarginesubcutaneous injection, variable dose, QD	Drug	2

Primary outcome

Change in HbA1c From Baseline to Week 26
Time frame: Baseline, Week 26
Change in HbA1c from baseline to Week 26

9 secondary outcomes

Percentage of Patients Achieving HbA1c <=7.0% at Week 26
Time frame: Baseline, Week 26
Percentage of Patients Achieving HbA1c <=6.5% at Week 26
Time frame: Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Body Weight (BW) From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Time frame: Baseline, Week 26
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26
Time frame: Baseline, Week 26
Ratio of Triglycerides at Week 26 to Baseline
Time frame: Baseline, Week 26
Change in Blood Pressure From Baseline to Week 26
Time frame: Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes
Time frame: Baseline to Week 26

Results and safety

Results posted to the registry on 4 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide Once Weekly	233	204
Insulin Glargine	234	209

Primary outcome: Change in HbA1c From Baseline to Week 26

Time frame: Baseline, Week 26. Least squares mean (Standard Error). Unit: percentage of total hemoglobin

Measure	Exenatide Once Weekly n = 205	Insulin Glargine n = 206
Value	-1.47 (0.05)	-1.31 (0.06)

Exenatide Once Weekly vs Insulin Glargine: Least Squares Mean Difference: -0.16 (95% CI -0.29 to -0.03), p = 0.017, Mixed Models Analysis

Population analysed: ITT Population: All randomized patients who had taken at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide Once Weekly	11 of 233 (4.7%)	100 of 233 (42.9%)	Not reported
Insulin Glargine	10 of 223 (4.5%)	52 of 223 (23.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22357185Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22.
Derived from this study: PubMed 32306296Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
Derived from this study: PubMed 24731672Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4.
Derived from this study: PubMed 23748506Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
Derived from this study: PubMed 23522121Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
Derived from this study: PubMed 22236356Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Derived from this study: PubMed 20609969Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.

Related trials for Type 2 Diabetes Mellitus

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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.

Chief Medical Officer, MD study director

Eli Lilly and Company

75 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide Once Weekly and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 75 sites in 16 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 22 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Germany, Spain, Australia, Netherlands and 11 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 4 Jul 2012). 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 26 (time frame: Baseline, 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 NCT00641056, which also lists 7 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 15 Jun 2015.