Type 2 Diabetes MellitusPhase 3NCT00676338

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

A Phase 3 study testing exenatide once weekly, metformin and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 106 sites in 22 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

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise. 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, metformin and sitagliptin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 820 participants
Where: 106 sitesin 22 countries
Study dates: Nov 2008to Jan 2011
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

have type 2 diabetes and are treated with diet and exercise alone.
at least 18 years of age.
HbA1c between 7.1% and 11.0%, inclusive.
Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Who cannot join

Have 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
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 history of severe GI disorder (e.g., gastroparesis)
Have a history of acute or chronic pancreatitis.
Have active proliferative retinopathy.

Show all 12Show fewer

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 with any antidiabetic agent for more than 7 days within 3 months prior to screening.
Have had an organ transplant.
Have previously completed or discontinued study drug in this study, 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

106 sites in 22 countries.

Country

City, postcode or hospital

106 sites in 22 countries

United States18 sites

Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Billings, Montana
Research Site
Buena Park, California
Research Site
Danville, Pennsylvania
Research Site
Des Moines, Iowa
Research Site
El Paso, Texas
Research Site
Grand Rapids, Michigan
Research Site
Jacksonville, Florida
Research Site
Los Angeles, California
Research Site
Meridian, Idaho
Research Site
Minneapolis, Minnesota
Research Site
New Branufels, Texas
Research Site
Philadelphia, Pennsylvania
Research Site
Toms River, New Jersey
Research Site
Valencia, California
Research Site
Wilke Barre, Pennsylvania
Research Site
Wilmington, North Carolina

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Canada9 sites

Research Site
Coquitlam, British Columbia
Research Site
Gatineu, Quebec
Research Site
Mississauga
Research Site
Ottawa, Ontario
Research Site
Penticton, British Columbia
Research Site
Petitcodiac
Research Site
Pointe-Claire
Research Site
Regina
Research Site
Saint John

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Brazil8 sites

Research Site
Brasília
Research Site
Campinas
Research Site
Curitiba
Research Site
Fortaleza
Research Site
Joinville
Research SIte
Porto Alegre
Research Site
Recife
Research Site
São Paulo

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United Kingdom8 sites

Research Site
Bath
Research Site
Birmingham
Research Site
Edinburgh
Research Site
Frome
Research Site
Guildford
Research Site
Hull
Research Site
Sheffield
Research Site
Swansea

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India7 sites

Research Site
Ahmedabad
Research Site
Bangalore
Research Site
Channai
Research Site
Kochi
Research Site
Mumbai
Research Site
New Dehli
Research SIte
Pune

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Russia5 sites

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

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South Korea5 sites

Research Site
Busan
Research Site
Daegu
Research Site
Jeonju
Research Site
Seoul
Research Site
Sungnam

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France4 sites

Research Site
Châteaugiron
Research Site
Mûrs-Erigné
Research Site
Nantes
Research Site
Vieux-Condé

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Germany4 sites

Research Site
Dresden
Research Site
Mainz
Research Site
Münster
Research Site
Rodgau

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Hungary4 sites

Research Site
Budapest
Research Site
Gyula
Research Site
Hódmezővásárhely
Research Site
Pécs

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South Africa4 sites

Research Site
Johannesburg
Research Site
Kempton Park
Research Site
Midrand
Research Site
Soweto

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Spain4 sites

Research Site
Alicante
Research Site
Barcelona
Research Site
Madrid
Research Site
Seville

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Belgium3 sites

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Leuven
Research Site
Marchovelette
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Tessenderlo

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Italy3 sites

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Florence
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Milan
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Siena

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Mexico3 sites

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Chihuahua City
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Guadalajara
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Monterrey

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Poland3 sites

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Lublin
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Szczecin
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Wroclaw

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Romania3 sites

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Galati
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Oradea
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Târgu Mureş

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Turkey (Türkiye)3 sites

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Ankara
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Istanbul
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Sisli-Istanbul

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Argentina2 sites

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Buenos Aires
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Mar del Plata

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Israel2 sites

Research Site
Holon
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Tel HaShomer

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Puerto Rico2 sites

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Manati
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Toa Baja

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Slovakia2 sites

Research Site
Bratislava
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Trebišov

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About this study

Official title: Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

Conditions: Type 2 Diabetes Mellitus
Being tested: exenatide once weekly, metformin, sitagliptin, pioglitazone
Keywords: Amylin, Lilly, exenatide once weekly, Byetta, Januvia, sitagliptin, thiazolidinedione
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.

exenatide once weeklyDrug
subcutaneous injection, 2mg, once weekly plus placebo oral once daily
metforminDrug
oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
sitagliptinDrug
oral, 100 mg, daily plus placebo once weekly subcutaneous injection
pioglitazoneDrug
oral, 30-45mg, daily plus placebo once weekly subcutaneous injection

Study groups in NCT00676338
Study group	Role	What they receive
Exenatide Once Weekly	Experimental	Not described Receives: Drug: exenatide once weekly
Metformin	Active comparator	Not described Receives: Drug: metformin
Sitagliptin	Active comparator	Not described Receives: Drug: sitagliptin
Pioglitazone	Active comparator	Not described Receives: Drug: pioglitazone

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
Percentage of Patients Achieving HbA1c <=7% at Week 26
Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).
Measured: Baseline, Week 26

Secondary outcomes (9)

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Change in FSG from baseline to Week 26.
Measured: Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Change in Body Weight from baseline to Week 26.
Measured: Baseline, Week 26
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
Change in Fasting TC from baseline to Week 26.
Measured: Baseline, Week 26
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
Change in Fasting HDL from baseline to Week 26.
Measured: Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.
Measured: Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).
Measured: Baseline to Week 26
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events
Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).
Measured: Baseline to Week 26
Change in Systolic Blood Pressure From Baseline to Week 26.
Change in Systolic Blood Pressure from baseline to Week 26.
Measured: Baseline, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26.
Change in Diastolic Blood Pressure from baseline to Week 26.
Measured: Baseline, Week 26

Timeline

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

Nov 2008Jan 2011

First posted13 May 2008 (estimated)
Study startNov 2008
Primary completionJul 2010
Study completionJan 2011

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 (5)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 820 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00676338
Sponsor's protocol ID: H8O-MC-GWCH (DURATION - 4)
Status last verified: Mar 2015
First submitted: 9 May 2008
Last updated: 9 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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
Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
PubMed 23748507
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
Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzalez JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 30.
PubMed 22210563

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 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00676338
Acronym / sponsor ID: H8O-MC-GWCH (DURATION - 4)
Conditions: Type 2 Diabetes Mellitus
Keywords: Amylin, Lilly, exenatide once weekly, Byetta, Januvia, sitagliptin, thiazolidinedione
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 820 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Nov 2008
Primary completion: Jul 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 13 May 2008 (estimated)
Results: Posted 26 Nov 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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Exenatide Once Weekly	Experimental	Drug: exenatide once weekly
Metformin	Active comparator	Drug: metformin
Sitagliptin	Active comparator	Drug: sitagliptin
Pioglitazone	Active comparator	Drug: pioglitazone

Who may qualify

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

Key inclusion criteria (5 listed)

have type 2 diabetes and are treated with diet and exercise alone.
at least 18 years of age.
HbA1c between 7.1% and 11.0%, inclusive.
Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Key exclusion criteria (12 listed)

Have 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
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 history of severe GI disorder (e.g., gastroparesis)
Have a history of acute or chronic pancreatitis.

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, 2mg, once weekly plus placebo oral once daily	Drug	Exenatide Once Weekly
metforminoral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection	Drug	Metformin
sitagliptinoral, 100 mg, daily plus placebo once weekly subcutaneous injection	Drug	Sitagliptin
pioglitazoneoral, 30-45mg, daily plus placebo once weekly subcutaneous injection	Drug	Pioglitazone

Primary outcome

Change in HbA1c From Baseline to Week 26
Time frame: Baseline, Week 26
Change in HbA1c from baseline to Week 26.
Percentage of Patients Achieving HbA1c <=7% at Week 26
Time frame: Baseline, Week 26
Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).

9 secondary outcomes

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
Time frame: Baseline, Week 26
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
Time frame: Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time frame: Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Time frame: Baseline to Week 26
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events
Time frame: Baseline to Week 26
Change in Systolic Blood Pressure From Baseline to Week 26.
Time frame: Baseline, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26.
Time frame: Baseline, Week 26

Results and safety

Results posted to the registry on 26 Nov 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	248	210
Metformin	246	213
Pioglitazone	163	133
Sitagliptin	163	140

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 = 218	Metformin n = 218	Pioglitazone n = 137	Sitagliptin n = 142
Value	-1.53 (0.07)	-1.48 (0.07)	-1.63 (0.08)	-1.15 (0.08)

Exenatide Once Weekly vs Metformin: Least Squares Mean Difference: -0.05 (98.3% CI -0.26 to 0.17), p = 0.620, Mixed Models Analysis
Exenatide Once Weekly vs Pioglitazone: Least Squares Mean Difference: 0.10 (98.3% CI -0.15 to 0.35), p = 0.328, Mixed Models Analysis
Exenatide Once Weekly vs Sitagliptin: Least Squares Mean Difference: -0.37 (98.3% CI -0.62 to -0.13), p <.001, Mixed Models Analysis

Population analysed: Intent to treat (ITT) population consisted of all randomized patients who had taken at least one dose of study drug. All scheduled post-baseline measurements were included in the analysis. Unscheduled visit observations were carried forward to the next scheduled visits.

Primary outcome: Percentage of Patients Achieving HbA1c <=7% at Week 26

Time frame: Baseline, Week 26. Number. Unit: percentage of patients

Measure	Exenatide Once Weekly n = 226	Metformin n = 232	Pioglitazone n = 150	Sitagliptin n = 143
Value	64.2	57.3	63.3	45.5

Exenatide Once Weekly vs Metformin: p = 0.151, Fisher Exact
Exenatide Once Weekly vs Pioglitazone: p = 0.913, Fisher Exact
Exenatide Once Weekly vs Sitagliptin: p <.001, Fisher Exact

Population analysed: ITT subjects with baseline HbA1c\>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.

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	4 of 248 (1.6%)	109 of 248 (44%)	Not reported
Metformin	12 of 246 (4.9%)	94 of 246 (38.2%)	Not reported
Pioglitazone	9 of 163 (5.5%)	57 of 163 (35%)	Not reported
Sitagliptin	3 of 163 (1.8%)	55 of 163 (33.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 23748507Malloy J, Meloni A, Han J. Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Postgrad Med. 2013 May;125(3):58-67. doi: 10.3810/pgm.2013.05.2661.
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 22210563Russell-Jones D, Cuddihy RM, Hanefeld M, Kumar A, Gonzalez JG, Chan M, Wolka AM, Boardman MK; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012 Feb;35(2):252-8. doi: 10.2337/dc11-1107. Epub 2011 Dec 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.

Chief Medical Officer, MD study director

Eli Lilly and Company

106 sites in 22 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, metformin and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 106 sites in 22 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 5 inclusion and 12 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada, Brazil, United Kingdom, India and 17 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 26 Nov 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). The study lists 2 primary outcomes in all. 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 NCT00676338, which also lists 5 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 9 Apr 2015.