Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 92 sites in 13 countries.

Completed

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

Trial summary

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,240 participants
Where: 92 sitesin 13 countries
Study dates: Apr 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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 Diabetes
Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs

Who cannot join

Type 1 Diabetes
Treatment with more than two additional oral antidiabetic drugs
Moderate and severe renal (kidney) failure or dysfunction

Trial locations and contacts

92 sites in 13 countries.

Country

City, postcode or hospital

92 sites in 13 countries

Canada18 sites

Research Site
Calgary, Alberta
Research Site
Chicoutimi, Quebec
Research Site
Etobicoke, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Kelowna, British Columbia
Research Site
Kingston, Ontario
Research Site
Langley, British Columbia
Research Site
London, Ontario
Research Site
Longueuil, Quebec
Research Site
Mirabel, Quebec
Research Site
Moncton, New Brunswick
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Oakville, Ontario
Research Site
Scarborough Village, Ontario
Research Site
Sherbrooke, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Thornhill, Ontario
Research Site
Winnipeg, Manitoba

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United States13 sites

Research Site
Chicago, Illinois
Research Site
Corpus Christi, Texas
Research Site
Dallas, Texas
Research Site
Fresno, California
Research Site
Greenbrae, California
Research Site
Indianapolis, Indiana
Research Site
Norfolk, Virginia
Research Site
Omaha, Nebraska
Research Site
Philadelphia, Pennsylvania
Research Site
Richmond, Virginia
Research Site
Roswell, Georgia
Research Site
Springfield, Illinois
Research Site
Tacoma, Washington

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Germany9 sites

Research Site
Bad Oeynhausen
Research Site
Dortmund
Research Site
Dresden
Research Site
Essen
Research Site
Frankfurt
Research Site
Magdeburg
Research Site
Münster
Research Site
Riesa
Research Site
Wolmirstedt

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Hungary9 sites

Research Site
Csongrád
Research Site
Esztergom
Research Site
Győr
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Komárom
Research Site
Miskolc
Research Site
Székesfehérvár
Research Site
Veszprém

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Finland8 sites

Research Site
Helsinki
Research Site
Joensuu
Research Site
Jyväskylä
Research Site
Kuopio
Research Site
Lahti, Finland
Research Site
Oulu
Research Site
Seinäjoki
Research Site
Turku

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United Kingdom8 sites

Research Site
Ashford
Research Site
Aylesbury, Bucks
Research Site
Birmingham
Research Site
Cardiff
Research Site
Liverpool
Research Site
Reading, Berks
Research Site
Reading
Research Site
Swansea

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Slovakia7 sites

Research Site
Bratislava
Research Site
Dolný Kubín
Research Site
Košice
Research Site
Levice
Research Site
Lučenec
Research Site
Považská Bystrica
Research Site
Prešov

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Bulgaria4 sites

Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Varna

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Netherlands4 sites

Research Site
Amersfoort
Research Site
Den Helder
Research Site
Leiden
Research Site
Rotterdam

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Spain4 sites

Research Site
Alicante, Valencia
Research Site
Madrid, Madrid
Research Site
Sabadell (barcelona), Catalonia
Research Site
Seville, Andalusia

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Romania3 sites

Research Site
Brasov, Brașov County
Research Site
Bucharest
Research Site
Tg Mures, Mureș County

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Russia3 sites

Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Saint Petersburg

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Austria2 sites

Research Site
Salzburg
Research Site
Vienna

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About this study

Official title: A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Placebo
Keywords: Dapagliflozin, efficacy, safety, add on to insulin, Oral AntiDiabetic, Type 2 diabetes
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.

DapagliflozinDrug
tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
DapagliflozinDrug
Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
DapagliflozinDrug
Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
PlaceboDrug
Placebo
DapagliflozinDrug
tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
DapagliflozinDrug
tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Study groups in NCT00673231
Study group	Role	What they receive
1	Experimental	2.5mg Receives: Drug: Dapagliflozin
2	Experimental	5mg Receives: Drug: Dapagliflozin
3	Experimental	10mg Receives: Drug: Dapagliflozin
4	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Adjusted Mean Change in HbA1c Levels
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.
Measured: Baseline to Week 24

Secondary outcomes (4)

Adjusted Mean Change in Body Weight
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.
Measured: Baseline to Week 24
Adjusted Mean Change in Calculated Mean Daily Insulin Dose
To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.
Measured: Baseline to Week 24
Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction
To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.
Measured: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.
Measured: Baseline to Week 24

Timeline

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

Apr 2008Jan 2011

First posted7 May 2008 (estimated)
Study startApr 2008
Primary completionMay 2009
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 (8)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00673231
Sponsor's protocol ID: D1690C00006
Status last verified: Sep 2013
First submitted: 6 May 2008
Last updated: 29 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
Aberle J, Menzen M, Schmid SM, Terkamp C, Jaeckel E, Rohwedder K, Scheerer MF, Xu J, Tang W, Birkenfeld AL. Dapagliflozin effects on haematocrit, red blood cell count and reticulocytes in insulin-treated patients with type 2 diabetes. Sci Rep. 2020 Dec 28;10(1):22396. doi: 10.1038/s41598-020-78734-z.
PubMed 33372185
Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
PubMed 33368935
Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
PubMed 26894924
van Haalen HG, Pompen M, Bergenheim K, McEwan P, Townsend R, Roudaut M. Cost effectiveness of adding dapagliflozin to insulin for the treatment of type 2 diabetes mellitus in the Netherlands. Clin Drug Investig. 2014 Feb;34(2):135-46. doi: 10.1007/s40261-013-0155-0.
PubMed 24243529
Wilding JP, Woo V, Rohwedder K, Sugg J, Parikh S; Dapagliflozin 006 Study Group. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014 Feb;16(2):124-36. doi: 10.1111/dom.12187. Epub 2013 Aug 29.
PubMed 23911013
Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Studiengruppe Dapagliflozin 006. [Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S27-38. doi: 10.1055/s-0032-1305284. Epub 2013 Mar 25. German.
PubMed 23529568
Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Dapagliflozin 006 Study Group. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):405-15. doi: 10.7326/0003-4819-156-6-201203200-00003.
PubMed 22431673

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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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin
ClinicalTrials.gov ID: NCT00673231
Acronym / sponsor ID: D1690C00006
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin, efficacy, safety, add on to insulin, Oral AntiDiabetic, Type 2 diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,240 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Apr 2008
Primary completion: May 2009 (actual)
Study completion: Jan 2011 (actual)
First posted: 7 May 2008 (estimated)
Results: Posted 23 Aug 2013

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: Dapagliflozin2.5mg
2	Experimental	Drug: Dapagliflozin5mg
3	Experimental	Drug: Dapagliflozin10mg
4	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Type 2 Diabetes
Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs

Key exclusion criteria (3 listed)

Type 1 Diabetes
Treatment with more than two additional oral antidiabetic drugs
Moderate and severe renal (kidney) failure or dysfunction

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
Dapagliflozintablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)	Drug	1
DapagliflozinTablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)	Drug	2
DapagliflozinTablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)	Drug	3
PlaceboPlacebo	Drug	4
Dapagliflozintablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)	Drug	1
Dapagliflozintablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg	Drug	3

Primary outcome

Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 24
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.

4 secondary outcomes

Adjusted Mean Change in Body Weight
Time frame: Baseline to Week 24
Adjusted Mean Change in Calculated Mean Daily Insulin Dose
Time frame: Baseline to Week 24
Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction
Time frame: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 23 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	197	168
Dapagliflozin 2.5mg	202	180
Dapagliflozin 5mg	212	186
Dapagliflozin 10mg	196	178

Primary outcome: Adjusted Mean Change in HbA1c Levels

Time frame: Baseline to Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Placebo n = 188	Dapagliflozin 2.5mg n = 198	Dapagliflozin 5mg n = 210	Dapagliflozin 10mg n = 192
Value	-0.30 (-0.40 to -0.20)	-0.75 (-0.85 to -0.65)	-0.82 (-0.92 to -0.73)	-0.90 (-1.00 to -0.80)

Placebo vs Dapagliflozin 2.5mg: Mean Difference (Final Values): -0.45 (95% CI -0.59 to -0.31), p <0.0001, ANCOVA
Placebo vs Dapagliflozin 5mg: Mean Difference (Final Values): -0.52 (95% CI -0.66 to -0.38), p <0.0001, ANCOVA
Placebo vs Dapagliflozin 10mg: Mean Difference (Final Values): -0.60 (95% CI -0.74 to -0.45), p <0.0001, ANCOVA

Population analysed: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier, or up to and incl the start date of extension period if earlier.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	14 of 197 (7.1%)	115 of 197 (58.4%)	Not reported
Dapagliflozin 2.5mg	15 of 202 (7.4%)	135 of 202 (66.8%)	Not reported
Dapagliflozin 5mg	10 of 212 (4.7%)	128 of 212 (60.4%)	Not reported
Dapagliflozin 10mg	14 of 196 (7.1%)	107 of 196 (54.6%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to insulin up-titration were used for outcome measures except for mean daily insulin dose which was evaluated regardless of.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Derived from this study: PubMed 33372185Aberle J, Menzen M, Schmid SM, Terkamp C, Jaeckel E, Rohwedder K, Scheerer MF, Xu J, Tang W, Birkenfeld AL. Dapagliflozin effects on haematocrit, red blood cell count and reticulocytes in insulin-treated patients with type 2 diabetes. Sci Rep. 2020 Dec 28;10(1):22396. doi: 10.1038/s41598-020-78734-z.
Derived from this study: PubMed 33368935Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
Derived from this study: PubMed 26894924Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
Derived from this study: PubMed 24243529van Haalen HG, Pompen M, Bergenheim K, McEwan P, Townsend R, Roudaut M. Cost effectiveness of adding dapagliflozin to insulin for the treatment of type 2 diabetes mellitus in the Netherlands. Clin Drug Investig. 2014 Feb;34(2):135-46. doi: 10.1007/s40261-013-0155-0.
Derived from this study: PubMed 23911013Wilding JP, Woo V, Rohwedder K, Sugg J, Parikh S; Dapagliflozin 006 Study Group. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014 Feb;16(2):124-36. doi: 10.1111/dom.12187. Epub 2013 Aug 29.
Derived from this study: PubMed 23529568Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Studiengruppe Dapagliflozin 006. [Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S27-38. doi: 10.1055/s-0032-1305284. Epub 2013 Mar 25. German.
Derived from this study: PubMed 22431673Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Dapagliflozin 006 Study Group. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):405-15. doi: 10.7326/0003-4819-156-6-201203200-00003.

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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.

John Wilding, MD principal investigator

Clinical Sciences CentreUniversity Hospital AintreeLongmoor LaneLiverpool, UK

92 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 92 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in Canada, United States, Germany, Hungary, Finland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Adjusted Mean Change in HbA1c Levels (time frame: Baseline to Week 24). 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 NCT00673231, 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 29 Oct 2013.