Type II DiabetesPhase 4NCT02429258

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

A Phase 4 study testing Farxiga, Metformin and Insulin in people with Type II Diabetes, run by AstraZeneca at 26 sites in United States.

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

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type II Diabetes
What is being tested?: Farxiga, Metformin and Insulin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 226 participants
Where: 26 sitesUnited States
Study dates: May 2015to Oct 2015
Phase: Phase 4
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus (T2DM)
Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
Body mass index (BMI) < or = to 45 kg/m2

Who cannot join

For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.
Use of sulfonylureas during the 8 weeks prior to screening
Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor
Ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening
Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Research Site
Bartlett, Tennessee
Research Site
Birmingham, Alabama
Research Site
Brooklyn, New York
Research Site
Cincinnati, Ohio
Research Site
Cooper City, Florida
Research Site
Dallas, Texas
Research Site
Dublin, Ohio
Research Site
Eugene, Oregon
Research Site
Evanston, Illinois
Research Site
Franklin, Ohio
Research Site
Greensboro, North Carolina
Research Site
Henderson, Nebraska
Research Site
Houston, Texas
Research Site
Huntington Park, California
Research Site
Hurst, Texas
Research Site
Lansdale, Pennsylvania
Research Site
Los Angeles, California
Research Site
Miami, Florida
Research Site
Oxon Hill, Maryland
Research Site
Phoenix, Arizona
Research Site
Renton, Washington
Research Site
Rochester, New York
Research Site
Sacramento, California
Research Site
San Diego, California
Research Site
Spartanburg, South Carolina
Research Site
West Hills, California

Other trials in United States

About this study

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Read the detailed description

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Conditions: Type II Diabetes
Being tested: Farxiga, Placebo, Metformin, Insulin
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.

FarxigaDrug
Farxiga 10mg/day
PlaceboDrug
Placebo
MetforminDrug
Metformin background therapy >/= 1500mg/day
InsulinDrug
Insulin >/= 30 units

Study groups in NCT02429258
Study group	Role	What they receive
Farxiga with metformin or insulin	Experimental	Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications Receives: Drug: Farxiga; Drug: Metformin; Drug: Insulin
Placebo with metformin or insulin	Placebo comparator	Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications Receives: Drug: Placebo; Drug: Metformin; Drug: Insulin

What is being measured

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

Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
Measured: Baseline to Week 4

Secondary outcomes (10)

Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Measured: Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
Measured: Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population
Measured: Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
Measured: Baseline to Week 4
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Measured: Baseline to Week 4
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
Measured: Baseline to Week 4
Change in HbA1c From Baseline to Week 4
Measured: Baseline to Week 4
Change in Fructosamine From Baseline to Week 4
Measured: Baseline to Week 4
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
Measured: Baseline to Week 4
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
Measured: Baseline to Week 4

Timeline

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

May 2015Oct 2015

First posted29 Apr 2015 (estimated)
Study startMay 2015
Primary completionOct 2015
Study completionOct 2015

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 (1)Papers the sponsor has linked to this study.
Other trials for Type II 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02429258
Sponsor's protocol ID: D1690L00026
Status last verified: Apr 2017
First submitted: 8 Apr 2015
Last updated: 14 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Henry RR, Strange P, Zhou R, Pettus J, Shi L, Zhuplatov SB, Mansfield T, Klein D, Katz A. Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Nov;20(11):715-724. doi: 10.1089/dia.2018.0052. Epub 2018 Sep 14.
PubMed 30222367

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 II Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
ClinicalTrials.gov ID: NCT02429258
Acronym / sponsor ID: D1690L00026
Conditions: Type II Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 29 Apr 2015 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

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

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Detailed description

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Study design

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

Arm	Type	Receives
Farxiga with metformin or insulin	Experimental	Drug: Farxiga, Drug: Metformin, Drug: InsulinFarxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
Placebo with metformin or insulin	Placebo comparator	Drug: Placebo, Drug: Metformin, Drug: InsulinPlacebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Type 2 diabetes mellitus (T2DM)
Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
Body mass index (BMI) < or = to 45 kg/m2

Key exclusion criteria (6 listed)

For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.
Use of sulfonylureas during the 8 weeks prior to screening
Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor
Ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening

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
FarxigaFarxiga 10mg/day	Drug	Farxiga with metformin or insulin
PlaceboPlacebo	Drug	Placebo with metformin or insulin
MetforminMetformin background therapy >/= 1500mg/day	Drug	Farxiga with metformin or insulin, Placebo with metformin or insulin
InsulinInsulin >/= 30 units	Drug	Farxiga with metformin or insulin, Placebo with metformin or insulin

Primary outcome

Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
Time frame: Baseline to Week 4

10 secondary outcomes

Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
Time frame: Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population
Time frame: Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
Time frame: Baseline to Week 4
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Time frame: Baseline to Week 4
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
Time frame: Baseline to Week 4
Change in HbA1c From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Fructosamine From Baseline to Week 4
Time frame: Baseline to Week 4
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
Time frame: Baseline to Week 4

Results and safety

Results posted to the registry on 11 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin	50	48
Placebo	50	49

Primary outcome: Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System

Time frame: Baseline to Week 4. Least squares mean (Standard Error). Unit: mg/dL

Measure	Dapagliflozin n = 50	Placebo n = 50
Value	-18.2 (4.33)	5.8 (4.25)

Dapagliflozin vs Placebo: Mean Difference (Final Values): -24.0 (95% CI -36.1 to -12.0), p <0.001, Mixed Models Analysis

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.05% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin	0 of 50 (0%)	3 of 50 (6%)	Not reported
Placebo	0 of 50 (0%)	3 of 50 (6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30222367Henry RR, Strange P, Zhou R, Pettus J, Shi L, Zhuplatov SB, Mansfield T, Klein D, Katz A. Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Nov;20(11):715-724. doi: 10.1089/dia.2018.0052. Epub 2018 Sep 14.

Related trials for Type II Diabetes

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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.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Farxiga, Metformin and Insulin in people with Type II Diabetes, run by AstraZeneca at 26 sites in United States.

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 4 inclusion and 6 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 11 Apr 2017). 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 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System (time frame: Baseline to Week 4). 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 NCT02429258, which also lists 1 linked publication.

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 Jun 2017.