Type 2 Diabetes MellitusPhase 3NCT00637273

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

A Phase 3 study testing exenatide once weekly, sitagliptin and pioglitazone in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 62 sites in 3 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 benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared. 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, sitagliptin and pioglitazone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 514 participants
Where: 62 sitesin 3 countries
Study dates: Jan 2008to Jul 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 been diagnosed with type 2 diabetes mellitus
Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
Hormone replacement therapy (female subjects)

Show all 12Show fewer

Oral contraceptives (female subjects)
Antihypertensive agents
Lipid-lowering agents
Thyroid replacement therapy
Antidepressant agents
Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents

Who cannot join

Has been previously exposed to exenatide once weekly
Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start

Show all 10Show fewer

Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

Trial locations and contacts

62 sites in 3 countries.

Country

City, postcode or hospital

62 sites in 3 countries

United States51 sites

Research Site
Artesia, California
Research Site
Athens, Ohio
Research Site
Austin, Texas
Research Site
Avon, Indiana
Research Site
Baton Rouge, Louisiana
Research Site
Boston, Massachusetts
Research Site
Butte, Montana
Research Site
Chelsea, Michigan
Research Site
Cincinnati, Ohio
Research Site
Colorado Springs, Colorado
Research Site
Concord, California
Research Site
Coral Gables, Florida
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Decatur, Georgia
Research Site
DeLand, Florida
Research Site
Durham, North Carolina
Research Site
Encino, California
Research Site
Greenbrae, California
Research Site
La Mesa, California
Research Site
Las Vegas, Nevada
Research Site
Lincoln, Nebraska
Research Site
Melbourne, Florida
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
New Hyde Park, New York
Research Site
New Orleans, Louisiana
Research Site
New Port Richey, Florida
Research Site
New Windsor, New York
Research Site
New York, New York
Research Site
Olympia, Washington
Research Site
Orange, California
Research Site
Oxon Hill, Maryland
Research Site
Paducah, Kentucky
Research Site
Peoria, Arizona
Research Site
Philadelphia, Pennsylvania
Research Site
Rapid City, South Dakota
Research Site
Richmond, Virginia
Research Site
Rochester, New York
Research Site
Saint Louis Park, Minnesota
Research Site
San Antonio, Texas
Research Site
Spokane, Washington
Research Site
St Louis, Missouri
Research Site
Statesville, North Carolina
Research Site
Tacoma, Washington
Research Site
Walnut Creek, California
Research Site
Washington D.C., District of Columbia
Research Site
Whittier, California
Research Site
Wichita, Kansas
Research Site
Winston-Salem, North Carolina
Research Site
Ypsilanti, Michigan

Other trials in United States

Mexico6 sites

Research Site
Cuernavaca, Morelos
Research Site
Guadalajara, Jalisco
Research Site
Mexico City, Mexico City
Research Site
Monterrey, NuevoLeon
Research Site
Toluca, State of Mexico
Research Site
Zapopan, Jalisco

Other trials in Mexico

India5 sites

Research Site
Bangalore
Research Site
Indore
Research Site
Karnāl
Research Site
Mumbai
Research Site
Pune

Other trials in India

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Conditions: Type 2 Diabetes Mellitus
Being tested: exenatide once weekly, sitagliptin, pioglitazone, placebo tablet, placebo once weekly
Keywords: diabetes, exenatide once weekly, Byetta, sitagliptin, Januvia, thiazolidinedione, Amylin, Lilly, Pioglitazone
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, 2.0mg, once a week
sitagliptinDrug
Also called Januvia
oral tablet, 100mg, once a day
pioglitazoneDrug
oral tablet, 45mg, once a day
placebo tabletDrug
oral tablet, once a day
placebo once weeklyDrug
subcutaneous injection, once a week

Study groups in NCT00637273
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: exenatide once weekly; Drug: placebo tablet
2	Active comparator	Not described Receives: Drug: sitagliptin; Drug: placebo once weekly
3	Active comparator	Not described Receives: Drug: pioglitazone; Drug: placebo once weekly

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
Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].
Measured: Day 1, Week 26

Secondary outcomes (11)

Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Percentages of subjects achieving HbA1c target values of <7% at Week 26.
Measured: Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
Measured: Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.
Measured: Week 26
Change in Body Weight From Baseline to Week 26
Change in body weight from baseline (Day 1) to Week 26.
Measured: Day 1, Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
Change in fasting plasma glucose from baseline (Day 1) to Week 26.
Measured: Day 1, Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
Change in systolic blood pressure from baseline (Day 1) to Week 26.
Measured: Day 1, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26
Change in diastolic blood pressure from baseline (Day 1) to Week 26.
Measured: Day 1, Week 26
Change in Fasting Total Cholesterol From Baseline to Week 26
Change in fasting total cholesterol from baseline (Day 1) to Week 26.
Measured: Day 1, Week 26
Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Change in fasting HDL from baseline (Day 1) to Week 26.
Measured: Day 1, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Measured: Day 1, Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Measured: Day 1 to Week 26

Timeline

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

Jan 2008Jul 2009

First posted17 Mar 2008 (estimated)
Study startJan 2008
Primary completionFeb 2009
Study completionJul 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 (8)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: 514 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00637273
Sponsor's protocol ID: BCB106 (DURATION - 2)
Status last verified: Mar 2015
First submitted: 6 Mar 2008
Last updated: 7 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
Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.
PubMed 23039868
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
Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x.
PubMed 21434995
Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26.
PubMed 20580422

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?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
ClinicalTrials.gov ID: NCT00637273
Acronym / sponsor ID: BCB106 (DURATION - 2)
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, exenatide once weekly, Byetta, sitagliptin, Januvia, thiazolidinedione, Amylin, Lilly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 514 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jan 2008
Primary completion: Feb 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 17 Mar 2008 (estimated)
Results: Posted 19 Jun 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: 3

Arm	Type	Receives
1	Experimental	Drug: exenatide once weekly, Drug: placebo tablet
2	Active comparator	Drug: sitagliptin, Drug: placebo once weekly
3	Active comparator	Drug: pioglitazone, Drug: placebo once weekly

Who may qualify

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

Key inclusion criteria (12 listed)

Has been diagnosed with type 2 diabetes mellitus
Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:

Key exclusion criteria (10 listed)

Has been previously exposed to exenatide once weekly
Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

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, 2.0mg, once a week	Drug	1
sitagliptinAlso: Januviaoral tablet, 100mg, once a day	Drug	2
pioglitazoneoral tablet, 45mg, once a day	Drug	3
placebo tabletoral tablet, once a day	Drug	1
placebo once weeklysubcutaneous injection, once a week	Drug	2, 3

Primary outcome

Change in HbA1c From Baseline to Week 26
Time frame: Day 1, Week 26
Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].

11 secondary outcomes

Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Time frame: Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Time frame: Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Time frame: Week 26
Change in Body Weight From Baseline to Week 26
Time frame: Day 1, Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
Time frame: Day 1, Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
Time frame: Day 1, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26
Time frame: Day 1, Week 26
Change in Fasting Total Cholesterol From Baseline to Week 26
Time frame: Day 1, Week 26
Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Time frame: Day 1, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time frame: Day 1, Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Time frame: Day 1 to Week 26

Results and safety

Results posted to the registry on 19 Jun 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	170	127
Sitagliptin	172	144
Pioglitazone	172	131

Primary outcome: Change in HbA1c From Baseline to Week 26

Time frame: Day 1, Week 26. Least squares mean (Standard Error). Unit: percentage of total hemoglobin

Measure	Exenatide Once Weekly n = 159	Sitagliptin n = 162	Pioglitazone n = 160
Value	-1.55 (0.100)	-0.92 (0.099)	-1.23 (0.099)

Exenatide Once Weekly vs Sitagliptin: Least Squares Mean Difference: 0.63 (95% CI 0.37 to 0.89), p <.0001, ANOVA
Exenatide Once Weekly vs Pioglitazone: Least Squares Mean Difference: 0.32 (95% CI 0.06 to 0.57), p = 0.0165, ANOVA

Population analysed: The ITT Population included randomized subjects who received at least one injection of study medication. Missing data up to Week 26 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.

11 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 160 (2.5%)	81 of 160 (50.6%)	Not reported
Sitagliptin	5 of 166 (3%)	59 of 166 (35.5%)	Not reported
Pioglitazone	10 of 165 (6.1%)	61 of 165 (37%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 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 23039868Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.
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 21434995Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011 Jun;28(6):705-14. doi: 10.1111/j.1464-5491.2011.03301.x.
Derived from this study: PubMed 20580422Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010 Aug 7;376(9739):431-9. doi: 10.1016/S0140-6736(10)60590-9. Epub 2010 Jun 26.

Related trials for Type 2 Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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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.

Lisa Porter, MD study director

Amylin Pharmaceuticals, LLC.

62 sites in 3 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, sitagliptin and pioglitazone in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 62 sites in 3 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 12 inclusion and 10 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 7 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 62 sites in United States, Mexico, India. 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 19 Jun 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: Day 1, 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 NCT00637273, which also lists 8 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 7 Apr 2015.