Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

A Phase 3 study testing exenatide in people with Type 2 Diabetes, run by AstraZeneca at 59 sites in 6 countries.

Completed

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

Trial summary

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 261 participants
Where: 59 sitesin 6 countries
Study dates: Oct 2008to Jan 2010
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.
Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.
Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:
metformin (stable dose for 6 weeks)
pioglitazone (stable dose for 6 weeks)
a combination of metformin and pioglitazone (stable dose for 6 weeks)

Show all 9Show fewer

Have HbA1C between 7.1% and 10.5%, inclusive.
Have a body mass index (BMI) ≤45 kg/m2.
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Who cannot join

Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
Women who are breastfeeding.
Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
Have had a kidney transplant or are currently on kidney dialysis.

Show all 18Show fewer

Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
Are currently on a weight-loss program or have been on one within 3 months of entering the study.
Have had a blood transfusion or severe blood loss within 3 months of entering the study.
Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
Have a history of pancreatitis.
Have received treatment with an experimental drug within 30 days of entering the study.
If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Trial locations and contacts

59 sites in 6 countries.

Country

City, postcode or hospital

59 sites in 6 countries

United States40 sites

Research Site
Albuquerque, New Mexico
Research Site
Atlanta, Georgia
Research Site
Baton Rouge, Louisiana
Research Site
Bend, Oregon
Research Site
Berkeley Heights, New Jersey
Research Site
Boston, Massachusetts
Research Site
Buena Park, California
Research Site
Chesterfield, Missouri
Research Site
Concord, California
Research Site
Dallas, Texas
Research Site
Des Moines, Iowa
Research Site
Durham, North Carolina
Research Site
El Paso, Texas
Research Site
Fresno, California
Research Site
Georgetown, Texas
Research Site
Greenbrae, California
Research Site
Hollywood, Florida
Research Site
Honolulu, Hawaii
Research Site
Idaho Falls, Idaho
Research Site
Jacksonville, Florida
Research Site
Kenosha, Wisconsin
Research Site
La Mesa, California
Research Site
Lafayette, Louisiana
Research Site
Lancaster, California
Research Site
Las Vegas, Nevada
Research Site
Matairie, Louisiana
Research Site
Minneapolis, Minnesota
Research SIte
New York, New York
Research Site
Northridge, California
Research Site
Omaha, Nebraska
Research Site
Palm Springs, California
Research Site
Peoria, Arizona
Research Site
Phoenix, Arizona
Research Site
Richmond, Virginia
Research Site
Salinas, California
Research Site
San Antonio, Texas
Research Site
St Louis, Missouri
Research SIte
Teaneck, New Jersey
Research Site
Vancouver, Washington
Research Site
Wichita, Kansas

Other trials in United States

United Kingdom7 sites

Research Site
Birmingham, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Livingston, United Kingdom
Research Site
Middlesbrough, United Kingdom
Research Site
Swansea, United Kingdom
Research Site
Torquay, United Kingdom

Other trials in United Kingdom

Puerto Rico4 sites

Research Site
Carolina
Research Site
Hato Rey
Research Site
Ponce
Research Site
San Juan

Other trials in Puerto Rico

Israel3 sites

Research Site
Holon, Israel
Research Site
Kfar Saba, Israel
Research Site
Tel HaShomer, Israel

Other trials in Israel

Mexico3 sites

Research Site
Coatzacoalcos, Mexico
Research Site
México, State of Mexico
Research Site
Monterrey, Mexico

Other trials in Mexico

Greece2 sites

Research Site
Athens, Greece
Research Site
Thessaloniki, Greece

Other trials in Greece

About this study

Official title: A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Conditions: Type 2 Diabetes
Being tested: placebo, exenatide
Keywords: diabetes, exenatide, Amylin, Lilly, metformin, pioglitazone, insulin glargine
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.

placeboDrug
subcutaneous injection, twice a day
exenatideDrug
subcutaneous injection, twice a day, 10mcg

Study groups in NCT00765817
Study group	Role	What they receive
1	Placebo comparator	Not described Receives: Drug: placebo
2	Experimental	Not described Receives: Drug: exenatide

What is being measured

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

Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.
Measured: baseline and 30 weeks

Secondary outcomes (16)

Percentage of Patients Achieving HbA1c <=7%
Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).
Measured: baseline and 30 weeks
Percentage of Patients Achieving HbA1c <=6.5%
Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).
Measured: baseline and 30 weeks
Change in Fasting Serum Glucose
Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
Measured: baseline and 30 weeks
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
Measured: baseline and 30 weeks
Change in Total Cholesterol
Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
Measured: baseline and 30 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
Measured: baseline and 30 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
Measured: baseline and 30 weeks
Change in Triglycerides
Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
Measured: baseline and 30 weeks
Change in Body Weight
Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
Measured: baseline and 30 weeks
Change in Waist Circumference
Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
Measured: baseline and 30 weeks
Change in Daily Insulin Dose
Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
Measured: baseline and 30 weeks
Change in Daily Insulin Dose (on a Per Body Weight Basis)
Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
Measured: baseline and 30 weeks
Change in Systolic Blood Pressure (SBP)
Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
Measured: baseline and 30 weeks
Change in Diastolic Blood Pressure (DBP)
Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
Measured: baseline and 30 weeks
Minor Hypoglycemia Rate Per Year
Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
Measured: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Percentage of Subjects Experiencing Minor Hypoglycemia
Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
Measured: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Timeline

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

Oct 2008Jan 2010

First posted3 Oct 2008 (estimated)
Study startOct 2008
Primary completionJan 2010
Study completionJan 2010

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 DiabetesStudies 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: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00765817
Sponsor's protocol ID: H8O-US-GWCO
Status last verified: Oct 2016
First submitted: 1 Oct 2008
Last updated: 24 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
PubMed 24621255
Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.
PubMed 23043166
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
PubMed 22913891
Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.
PubMed 22432107
Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.
PubMed 21138825

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications
ClinicalTrials.gov ID: NCT00765817
Acronym / sponsor ID: H8O-US-GWCO
Conditions: Type 2 Diabetes
Keywords: diabetes, exenatide, Amylin, Lilly, metformin, pioglitazone, insulin glargine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Oct 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 3 Oct 2008 (estimated)
Results: Posted 26 Jan 2011

Clinical summary

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

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Placebo comparator	Drug: placebo
2	Experimental	Drug: exenatide

Who may qualify

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

Key inclusion criteria (9 listed)

Have type 2 diabetes.
Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.
Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:
metformin (stable dose for 6 weeks)
pioglitazone (stable dose for 6 weeks)

Key exclusion criteria (18 listed)

Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
Women who are breastfeeding.
Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.

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
placebosubcutaneous injection, twice a day	Drug	1
exenatidesubcutaneous injection, twice a day, 10mcg	Drug	2

Primary outcome

Change in Glycosylated Hemoglobin (HbA1c)
Time frame: baseline and 30 weeks
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.

16 secondary outcomes

Percentage of Patients Achieving HbA1c <=7%
Time frame: baseline and 30 weeks
Percentage of Patients Achieving HbA1c <=6.5%
Time frame: baseline and 30 weeks
Change in Fasting Serum Glucose
Time frame: baseline and 30 weeks
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Time frame: baseline and 30 weeks
Change in Total Cholesterol
Time frame: baseline and 30 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame: baseline and 30 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame: baseline and 30 weeks
Change in Triglycerides
Time frame: baseline and 30 weeks
Change in Body Weight
Time frame: baseline and 30 weeks
Change in Waist Circumference
Time frame: baseline and 30 weeks
Change in Daily Insulin Dose
Time frame: baseline and 30 weeks
Change in Daily Insulin Dose (on a Per Body Weight Basis)
Time frame: baseline and 30 weeks
Change in Systolic Blood Pressure (SBP)
Time frame: baseline and 30 weeks
Change in Diastolic Blood Pressure (DBP)
Time frame: baseline and 30 weeks
Minor Hypoglycemia Rate Per Year
Time frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Percentage of Subjects Experiencing Minor Hypoglycemia
Time frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Results and safety

Results posted to the registry on 26 Jan 2011, 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 Arm	138	112
Placebo Arm	123	101

Primary outcome: Change in Glycosylated Hemoglobin (HbA1c)

Time frame: baseline and 30 weeks. Least squares mean (Standard Error). Unit: percentage of hemoglobin

Measure	Exenatide Arm n = 112	Placebo Arm n = 100
Value	-1.71 (0.09)	-1.00 (0.09)

Exenatide Arm vs Placebo Arm: p <0.001, ANCOVA

Population analysed: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

16 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 Arm	8 of 137 (5.8%)	109 of 138 (79%)	Not reported
Placebo Arm	11 of 122 (9%)	66 of 123 (53.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24621255Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
Derived from this study: PubMed 23043166Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.
Derived from this study: PubMed 22913891Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Derived from this study: PubMed 22432107Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.
Derived from this study: PubMed 21138825Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

59 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide in people with Type 2 Diabetes, run by AstraZeneca at 59 sites in 6 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 9 inclusion and 18 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, United Kingdom, Puerto Rico, Israel, Mexico and 1 more country. 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 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 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Hemoglobin (HbA1c) (time frame: baseline and 30 weeks). 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 NCT00765817, 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 24 Oct 2016.