Diabetes Mellitus, Type 2Phase 2/3NCT00663260
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
A Phase 2/3 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 96 sites in 13 countries.
Trial summary
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- 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
- 631 participants
- Where
- 96 sitesin 13 countries
- Study dates
- Jun 2008to Jun 2011
- Phase
- Phase 2/3
- 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
- Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
- Clinical diagnosis of moderate renal impairment
Who cannot join
- AST and /or ALT > 3.0 times the upper limit of normal
- Serum total bilirubin > 1.5 times ULN
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Trial locations and contacts
96 sites in 13 countries.
96 sites in 13 countries
United States34 sites
Community Health Care Of Manchester
Akron, Ohio, 44319
Center For Thyroid Diseases And Endocrinology
Beachwood, Ohio, 44122
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
Low Country Internal Medicine Of Sc, Pa
Charleston, South Carolina, 29406
Research Institute Of Dallas
Dallas, Texas, 75231
Endocrine Associates Of The Rockies
Denver, Colorado, 80220
Valley Research
Fresno, California, 93720
Marin Endocrine Care & Research, Inc.
Greenbrae, California, 94904
Westbury Medical Clinic P.A.
Houston, Texas, 77005
Kcva Medical Center Research Svc (151)
Kansas City, Missouri, 64128
Office Of Richard Cherlin, Md
Los Gatos, California, 95032
Panhandle Family Care Associates
Marianna, Florida, 32446
Rogue Valley Clinical Research
Medford, Oregon, 97504
Vista Medical Research, Inc.
Mesa, Arizona, 85206
Aurora Advanced Healthcare
Milwaukee, Wisconsin, 53209
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, 53295
Winthrop University Hospital
Mineola, New York, 11501
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
Slocum-Dickson Medical Group, Pllc
New Hartford, New York, 13413
The Strelitz Diabetes Center
Norfolk, Virginia, 23510
Diabetes Medical Center Of California
Northridge, California, 91325
Univ Of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Capital Clinical Research Center
Olympia, Washington, 98502
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, 68105
Drexel University College Of Medicine
Philadelphia, Pennsylvania, 19102
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Apex Research Of Riverside
Riverside, California, 92505
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Palmetto Clinical Research
Summerville, South Carolina, 29485
Cedar Research Llc
Tacoma, Washington, 98405
Genesis Clinical Research
Tampa, Florida, 33614
La Biomed At Harbor Ucla Med Ctr.
Torrance, California, 90502
University Of Medicine And Dentistry Of New Jersey
Voorhees Township, New Jersey, 08043
Physician Research, Inc.
Zanesville, Ohio, 43701
Canada10 sites
Local Institution
Barrie, Ontario, L4M 7G1
Local Institution
Calgary, Alberta, T3B 0M3
Local Institution
Gatineau, Quebec, J8V 2P5
Local Institution
Laval, Quebec, H7T 2P5
Local Institution
Regina, Saskatchewan, S4P 0W5
Local Institution
Sherbrooke, Quebec, J1G 5K2
Local Institution
Thornhill, Ontario, L4J 8L7
Local Institution
Toronto, Ontario, M4N 3M5
Local Institution
Toronto, Ontario, M4R 2G4
Local Institution
Winnipeg, Manitoba, R3E 3P4
Argentina8 sites
Local Institution
Buenos Aires, Buenos Aires, C1012AAR
Local Institution
Buenos Aires, Buenos Aires, C1408INH
Local Institution
Capital Federal, Buenos Aires, C1405BCJ
Local Institution
Córdoba, Córdoba Province, 5000
Local Institution
Córdoba, Córdoba Province, X5006CBI
Local Institution
Mar del Plata, Buenos Aires, 7600
Local Institution
Salta, Salta Province, A4406CLA
Local Institution
Zárate, Buenos Aires, 2800
Italy8 sites
Local Institution
Chieri, 10023
Local Institution
Chieti Scalo, 66013
Local Institution
Modena, 41100
Local Institution
Padova, 35128
Local Institution
Perugia, 06126
Local Institution
Pisa, 56126
Local Institution
Roma, 00189
Local Institution
Siena, 53100
India7 sites
Local Institution
Bangalore, 560 052
Local Institution
Bangalore, 560034
Local Institution
Chennai, 600029
Local Institution
Indore, Madhya Pradesh, 452001
Local Institution
Pune, Maharashtra, 411 004
Local Institution
Pune, Maharashtra, 411011
Local Institution
Rajasthan, 302 001
Mexico7 sites
Local Institution
Celaya, Guanajuato, 38000
Local Institution
Df, Mexico City, 01120
Local Institution
Df, Mexico City, 06700
Local Institution
Df, Mexico City, 11800
Local Institution
Durango, Durango, 34075
Local Institution
Guadalajara, Jalisco, 44670
Local Institution
Monterrey, Nuevo León, 64460
France5 sites
Local Institution
Besançon, 25030
Local Institution
Brest, 29609
Local Institution
Paris, 75475
Local Institution
Paris, 75877
Local Institution
Poitiers, 86021
Australia4 sites
Local Institution
Camperdown, New South Wales, 2050
Local Institution
Launceston, Tasmania, 7250
Local Institution
St Leonards, New South Wales, 2065
Local Institution
Woollongong, New South Wales, 2500
Peru4 sites
Local Institution
Arequipa, Arequipa
Local Institution
Lima, Lima Province, 18
Local Institution
Lima, Lima Province, LIMA 13
Local Institution
Lima Cercado, Lima region, 1
Denmark3 sites
Local Institution
Copenhagen Nv, 2400
Local Institution
Gentofte Municipality, 2820
Local Institution
Hvidovre, 2650
Spain3 sites
Local Institution
Barcelona, 08036
Local Institution
San Sebastian de Los, 28702
Local Institution
Vizcaya, 48903
Puerto Rico2 sites
Local Institution
Caguas, 00725
Local Institution
San Juan, 00909
About this study
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
Read the detailed description
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin, Placebo
- 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, 104 weeks
DapagliflozinDrug
Also called BMS-512148
Tablets, Oral, 5 mg, Once Daily, 104 weeks
PlaceboDrug
Tablets, Oral, 0 mg, Once Daily, 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin (10 mg) | Active comparator | Not described Receives: Drug: Dapagliflozin |
| Dapagliflozin (5 mg) | Active comparator | Not described Receives: Drug: Dapagliflozin |
| Placebo | 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 From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
HbA1c was measured as percent of hemoglobin by a central laboratory. 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.
Measured: From Baseline to Week 24
Secondary outcomes (2)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period
Measured: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.
Measured: From 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.
- First posted22 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionJun 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 (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663260
- Sponsor's protocol ID
- MB102-029
- Status last verified
- Dec 2016
- First submitted
- 18 Apr 2008
- Last updated
- 10 Feb 2017
- 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 38770818Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.
PubMed 27306615Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.
PubMed 24067431
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00663260
- Acronym / sponsor ID
- MB102-029
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 10 Feb 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 determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
Detailed description
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin (10 mg) | Active comparator | Drug: Dapagliflozin |
| Dapagliflozin (5 mg) | Active comparator | Drug: Dapagliflozin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
- Clinical diagnosis of moderate renal impairment
Key exclusion criteria (4 listed)
- AST and /or ALT > 3.0 times the upper limit of normal
- Serum total bilirubin > 1.5 times ULN
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
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, 104 weeks | Drug | Dapagliflozin (10 mg) |
| DapagliflozinAlso: BMS-512148Tablets, Oral, 5 mg, Once Daily, 104 weeks | Drug | Dapagliflozin (5 mg) |
| PlaceboTablets, Oral, 0 mg, Once Daily, 104 weeks | Drug | Placebo |
Primary outcome
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
Time frame: From Baseline to Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.
2 secondary outcomes
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- 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 27306615Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.
- Derived from this study: PubMed 24067431Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.
- PublicationLink provided by the sponsor.
- Publication long-termLink provided by the sponsor.
- MB102029\_Redacted\_CSR\_synopsisLink provided by the sponsor.
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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
96 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 96 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 4 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Canada, Argentina, Italy, India 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 combined 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.
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 10 Feb 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 Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF] (time frame: From 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 NCT00663260, which also lists 3 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 10 Feb 2017.