Type 2 Diabetes MellitusPhase 2NCT00976495

Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

A Phase 2 study testing Dapagliflozin and Hydrochlorothiazide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 12 sites in 3 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

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin and Hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 12 sitesin 3 countries
Study dates: Oct 2009to Nov 2010
Phase: Phase 2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and < 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and < 105 mmHg
C-peptide ≥ 0.8 ng/mL
Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula > 60 mL/min/1.73m² and < 150 mL/min/1.73m²
Urine albumin:creatinine ratio (UACR) < 300 mg/g
BMI ≤ 45.0 kg/m2

Who cannot join

Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit
History of adverse reaction to radio-contrast dye
Allergy or contraindication to use of thiazide diuretics
Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)
Alanine aminotransferase (ALT) > 3X ULN
Serum Total Bilirubin > 1.5X ULN
Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

United States9 sites

Advanced Clinical Res Inst
Anaheim, California, 92801
University Of Michigan
Ann Arbor, Michigan, 48106
Torrance Clinical Research
Lomita, California, 90717
Elite Research Institute
Miami, Florida, 33169
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, 53295
Compass Research, Llc
Orlando, Florida, 32806
Orlando Clinical Research Center
Orlando, Florida, 32809
Memorial Hospital Of Rhode Island
Pawtucket, Rhode Island, 02860
Prism Research
Saint Paul, Minnesota, 55114

Other trials in United States

Canada2 sites

Local Institution
Laval, Quebec, H7T 2P5
Local Institution
Toronto, Ontario, M4G 3E8

Other trials in Canada

Netherlands1 site

Local Institution
Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic and Blood Pressure (BP) Control

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin, Placebo, Hydrochlorothiazide
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
Also called BMS-512148
Tablets, Oral, 10 mg, once daily, 12 weeks
PlaceboDrug
Tablets, Oral, 0 mg, once daily, 12 weeks
HydrochlorothiazideDrug
Tablets, Oral, 25 mg, once daily, 12 weeks

Study groups in NCT00976495
Study group	Role	What they receive
Dapagliflozin	Experimental	Not described Receives: Drug: Dapagliflozin; Drug: Placebo
Hydrochlorothiazide	Active comparator	Not described Receives: Drug: Hydrochlorothiazide

What is being measured

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

Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.
Measured: From Baseline to Week 12

Secondary outcomes (3)

Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.
Measured: From Baseline to Week 12
Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.
Measured: From Baseline to Week 12
Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.
Measured: From Baseline to Week 12

Timeline

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

Oct 2009Nov 2010

First posted14 Sep 2009 (estimated)
Study startOct 2009
Primary completionNov 2010
Study completionNov 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.
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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00976495
Sponsor's protocol ID: MB102-035
Other IDs: EUDRACT #: 2009-010221-39
Status last verified: Jan 2017
First submitted: 11 Sep 2009
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic and Blood Pressure (BP) Control
ClinicalTrials.gov ID: NCT00976495
Acronym / sponsor ID: MB102-035
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Astra Zeneca, Bristol-Myers Squibb
Study start: Oct 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 14 Sep 2009 (estimated)
Results: Posted 8 Mar 2017

Clinical summary

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

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: Dapagliflozin, Drug: Placebo
Hydrochlorothiazide	Active comparator	Drug: Hydrochlorothiazide

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and < 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and < 105 mmHg
C-peptide ≥ 0.8 ng/mL
Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula > 60 mL/min/1.73m² and < 150 mL/min/1.73m²

Key exclusion criteria (8 listed)

Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit
History of adverse reaction to radio-contrast dye
Allergy or contraindication to use of thiazide diuretics
Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)
Alanine aminotransferase (ALT) > 3X ULN

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
DapagliflozinAlso: BMS-512148Tablets, Oral, 10 mg, once daily, 12 weeks	Drug	Dapagliflozin
PlaceboTablets, Oral, 0 mg, once daily, 12 weeks	Drug	Dapagliflozin
HydrochlorothiazideTablets, Oral, 25 mg, once daily, 12 weeks	Drug	Hydrochlorothiazide

Primary outcome

Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])
Time frame: From Baseline to Week 12
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.

3 secondary outcomes

Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 12
Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 12
Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 12

Results and safety

Results posted to the registry on 8 Mar 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
Placebo	25	25
Dapagliflozin 10 mg	24	23
Hydrochlorothiazide 25 mg	26	26

Primary outcome: Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])

Time frame: From Baseline to Week 12. Mean (Standard Error). Unit: % Change of Baseline GFR

Measure	Placebo n = 25	Dapagliflozin 10 mg n = 22	Hydrochlorothiazide 25 mg n = 26
Value	-2.92 (2.0133)	-10.76 (1.9684)	-3.40 (1.9756)

Placebo vs Dapagliflozin 10 mg: Mean Difference (Final Values): -8.07 (95% CI -13.34 to -2.49)
Dapagliflozin 10 mg vs Hydrochlorothiazide 25 mg: Mean Difference (Final Values): -7.62 (95% CI -12.87 to -2.06)

Population analysed: All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	2 of 25 (8%)	Not reported
Dapagliflozin 10 mg	3 of 24 (12.5%)	6 of 24 (25%)	Not reported
Hydrochlorothiazide 25 mg	0 of 26 (0%)	9 of 26 (34.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
PublicationLink provided by the sponsor.
MB102035\_Redacted\_CSR\_synopsisLink provided by the sponsor.

Related trials for Type 2 Diabetes Mellitus

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Active, not recruiting
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Recruiting
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Not yet recruitingPhase 3
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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin and Hydrochlorothiazide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 12 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 7 inclusion and 8 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 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Mar 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?

Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF]) (time frame: From Baseline to Week 12). 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 NCT00976495.

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 8 Mar 2017.