Type 2 Diabetes MellitusPhase 3NCT00855166

Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

A Phase 3 study testing Dapagliflozin, Metformin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 21 sites in 5 countries.

Completed

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

Official record

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Trial summary

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone. Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin, Metformin and Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 182 participants
Where: 21 sitesin 5 countries
Study dates: Feb 2009to Dec 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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
≥30 years for males
≥55 years for females

Who cannot join

Type 1 Diabetes
Body weight change >5% within 3 months prior to enrolment
Renal and liver impairment

Trial locations and contacts

21 sites in 5 countries.

Country

City, postcode or hospital

21 sites in 5 countries

Sweden6 sites

Research Site
Gothenburg
Research Site
Jarfalla
Research Site
Lund
Research Site
Malmö
Research Site
Stockholm
Research Site
Uppsala

Other trials in Sweden

Czechia5 sites

Research Site
Beroun
Research Site
Brno
Research Site
Prague
Research Site
Semily
Research Site
Slaný

Other trials in Czechia

Hungary5 sites

Research Site
Balatonfüred
Research Site
Budapest
Research Site
Csongrád
Research Site
Kecskemét
Research Site
Tát

Other trials in Hungary

Poland3 sites

Research Site
Elblag
Research Site
Krakow
Research Site
Torun

Other trials in Poland

Bulgaria2 sites

Research Site
Blagoevgrad
Research Site
Sofia

Other trials in Bulgaria

About this study

Official title: A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin, Metformin, Sitagliptin, Placebo
Keywords: Dapagliflozin, Metformin, Type 2 diabetes, body weight
Medical subject headings: Diabetes Mellitus, Type 2, Body Weight

What participants receive

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

DapagliflozinDrug
Tablet oral 10 mg total daily dose once daily 102 weeks
MetforminDrug
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
SitagliptinDrug
Tablet oral 100 mg total daily dose once daily rescue medication
PlaceboDrug
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Study groups in NCT00855166
Study group	Role	What they receive
A	Experimental	Dapagliflozin 10 mg plus Metformin Receives: Drug: Dapagliflozin; Drug: Metformin; Drug: Sitagliptin
B	Placebo comparator	Placebo plus Metformin Receives: Drug: Metformin; Drug: Sitagliptin; Drug: Placebo

What is being measured

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

Adjusted Mean Change in Total Body Weight
To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.
Measured: Baseline to Week 24

Secondary outcomes (3)

Adjusted Mean Change in Waist Circumference
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.
Measured: Baseline to Week 24
Adjusted Mean Change in Body Fat Mass
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.
Measured: Baseline to Week 24
Proportion of Participants With Body Weight Decrease ≥5%
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.
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.

Feb 2009Dec 2011

First posted4 Mar 2009 (estimated)
Study startFeb 2009
Primary completionJun 2010
Study completionDec 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 (4)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: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00855166
Sponsor's protocol ID: D1690C00012
Status last verified: Aug 2013
First submitted: 3 Mar 2009
Last updated: 14 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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
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
Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
PubMed 23906445
Ljunggren O, Bolinder J, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 Nov;14(11):990-9. doi: 10.1111/j.1463-1326.2012.01630.x. Epub 2012 Jun 29.
PubMed 22651373

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 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
ClinicalTrials.gov ID: NCT00855166
Acronym / sponsor ID: D1690C00012
Conditions: Type 2 Diabetes Mellitus
Keywords: Dapagliflozin, Metformin, Type 2 diabetes, body weight
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Feb 2009
Primary completion: Jun 2010 (actual)
Study completion: Dec 2011 (actual)
First posted: 4 Mar 2009 (estimated)
Results: Posted 14 Oct 2013

Clinical summary

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

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Study design

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

Arm	Type	Receives
A	Experimental	Drug: Dapagliflozin, Drug: Metformin, Drug: SitagliptinDapagliflozin 10 mg plus Metformin
B	Placebo comparator	Drug: Metformin, Drug: Sitagliptin, Drug: PlaceboPlacebo plus Metformin

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 diabetes
Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
≥30 years for males
≥55 years for females

Key exclusion criteria (3 listed)

Type 1 Diabetes
Body weight change >5% within 3 months prior to enrolment
Renal and liver impairment

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 10 mg total daily dose once daily 102 weeks	Drug	A
MetforminTablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks	Drug	A, B
SitagliptinTablet oral 100 mg total daily dose once daily rescue medication	Drug	A, B
PlaceboMatching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks	Drug	B

Primary outcome

Adjusted Mean Change in Total Body Weight
Time frame: Baseline to Week 24
To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.

3 secondary outcomes

Adjusted Mean Change in Waist Circumference
Time frame: Baseline to Week 24
Adjusted Mean Change in Body Fat Mass
Time frame: Baseline to Week 24
Proportion of Participants With Body Weight Decrease ≥5%
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 14 Oct 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 Plus Metformin	91	86
Dapagliflozin Plus Metformin	91	83

Primary outcome: Adjusted Mean Change in Total Body Weight

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

Measure	Placebo Plus Metformin n = 91	Dapagliflozin Plus Metformin n = 89
Value	-0.88 (0.2746)	-2.96 (0.2766)

Placebo Plus Metformin vs Dapagliflozin Plus Metformin: Mean Difference (Final Values): -2.08 (95% CI -2.84 to -1.31), p <0.0001, ANCOVA

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

3 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including 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 Plus Metformin	1 of 91 (1.1%)	9 of 91 (9.9%)	Not reported
Dapagliflozin Plus Metformin	6 of 91 (6.6%)	7 of 91 (7.7%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 24 weeks, last observation carried forward (LOCF) was used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 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 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 23906445Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
Derived from this study: PubMed 22651373Ljunggren O, Bolinder J, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 Nov;14(11):990-9. doi: 10.1111/j.1463-1326.2012.01630.x. Epub 2012 Jun 29.

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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.

Jan Bolinder, MD, PhD principal investigator

Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden

21 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin, Metformin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 21 sites in 5 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 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 14 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 21 sites in Sweden, Czechia, Hungary, Poland, Bulgaria. 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 14 Oct 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 Total Body Weight (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 NCT00855166, which also lists 4 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 14 Oct 2013.