A Phase 2/3 interventional study of Dapagliflozin and Dapagliflozin in Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed at 96 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by AstraZeneca · Phase 2/3, Interventional, and Treatment
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
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 631 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Dapagliflozin
Drug: Dapagliflozin
Drug: Placebo
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Also known as: BMS-512148
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Also known as: BMS-512148
Tablets, Oral, 0 mg, Once Daily, 104 weeks
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.
Time frame: From Baseline to Week 24
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
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])
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.
Time frame: From Baseline to Week 24
Of 631 participants enrolled, 276 completed a qualification period. Of these 276 participants, 252 were randomized and received treatment. Of these 252 participants, 204 completed double-blind treatment period.
| Milestone | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg |
|---|---|---|---|
| Started | 84 | 83 | 85 |
| Completed | 63 | 72 | 69 |
| Not completed | 21 | 11 | 16 |
| Withdrew: Lack of efficacy | 2 | 0 | 0 |
| Withdrew: Adverse event | 12 | 7 | 6 |
| Withdrew: Withdrawal by subject | 3 | 1 | 6 |
| Withdrew: Death | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Non-compliance, not met criteria, etc. | 3 | 2 | 3 |
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.
| % of hemoglobin | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg |
|---|---|---|---|
| Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF] | -0.32 ± 0.1701 | -0.41 ± 0.1701 | -0.44 ± 0.1708 |
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
| mg/dL | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg |
|---|---|---|---|
| Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) | 8.4 ± 9.621 | -5.2 ± 9.548 | -0.6 ± 9.524 |
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.
| kg | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg |
|---|---|---|---|
| Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | 0.27 ± 0.4872 | -1.54 ± 0.4815 | -1.89 ± 0.4693 |
Collected over Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 9/84 (10.7%) | 39/84 (46.4%) |
| Dapagliflozin 5 mg | — | 7/83 (8.4%) | 45/83 (54.2%) |
| Dapagliflozin 10 mg | — | 12/85 (14.1%) | 42/85 (49.4%) |
| Event | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg |
|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 2/84 | 0/83 | 0/85 |
| HYPOGLYCAEMIAMetabolism and nutrition disorders | 0/84 | 0/83 | 2/85 |
| CARDIAC FAILURECardiac disorders | 0/84 | 1/83 | 0/85 |
| CARDIOMYOPATHYCardiac disorders | 0/84 | 1/83 | 0/85 |
| CELLULITISInfections and infestations | 0/84 | 1/83 | 0/85 |
| PNEUMONIAInfections and infestations | 0/84 | 1/83 | 0/85 |
| ANAEMIABlood and lymphatic system disorders | 0/84 | 1/83 | 0/85 |
| SPONDYLOLISTHESISMusculoskeletal and connective tissue disorders | 0/84 | 1/83 | 0/85 |
| BALANOPOSTHITISReproductive system and breast disorders | 0/84 | 1/83 | 0/85 |
| INGUINAL HERNIAGastrointestinal disorders | 1/84 | 0/83 | 0/85 |
| Event | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg |
|---|---|---|---|
| DIZZINESSNervous system disorders | 4/84 | 10/83 | 5/85 |
| HYPERKALAEMIAMetabolism and nutrition disorders | 10/84 | 7/83 | 5/85 |
| POLLAKIURIARenal and urinary disorders | 3/84 | 5/83 | 10/85 |
| COUGHRespiratory, thoracic and mediastinal disorders | 2/84 | 8/83 | 8/85 |
| OEDEMA PERIPHERALGeneral disorders | 4/84 | 8/83 | 4/85 |
| DIARRHOEAGastrointestinal disorders | 3/84 | 3/83 | 8/85 |
| BACK PAINMusculoskeletal and connective tissue disorders | 6/84 | 7/83 | 2/85 |
| MUSCULOSKELETAL PAINMusculoskeletal and connective tissue disorders | 3/84 | 3/83 | 7/85 |
| NAUSEAGastrointestinal disorders | 1/84 | 3/83 | 7/85 |
| NASOPHARYNGITISInfections and infestations | 5/84 | 6/83 | 4/85 |
All randomized participants who received at least 1 dose of study medication
| Age, Continuous(Years) | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg | Total |
|---|---|---|---|---|
| Mean | 67 ± 8.6 | 66 ± 8.9 | 68 ± 7.7 | 67 ± 8.4 |
| Age, Customized(Participants) | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg | Total |
|---|---|---|---|---|
| Younger than 65 years | 36 | 39 | 29 | 104 |
| 65 years and older | 48 | 44 | 56 | 148 |
| Sex/Gender, Customized(Participants) | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg | Total |
|---|---|---|---|---|
| Male | 53 | 55 | 56 | 164 |
| Female | 31 | 28 | 29 | 88 |
| Race/Ethnicity, Customized(Participants) | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg | Total |
|---|---|---|---|---|
| WHITE | 69 | 65 | 77 | 211 |
| BLACK OR AFRICAN AMERICAN | 1 | 7 | 4 | 12 |
| ASIAN | 6 | 4 | 3 | 13 |
| OTHER | 8 | 7 | 1 | 16 |
| Weight(kg) | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg | Total |
|---|---|---|---|---|
| Mean | 89.61 ± 20.046 | 95.23 ± 20.909 | 93.25 ± 17.309 | 92.69 ± 19.529 |
| Pre-Enrollment Anti-Hyperglycemic Therapy(Participants) | Placebo | Dapagliflozin 5 mg | Dapagliflozin 10 mg | Total |
|---|---|---|---|---|
| INSULIN-BASED REGIMEN | 55 | 54 | 55 | 164 |
| SULFONYLUREA-BASED REGIMEN | 21 | 21 | 21 | 63 |
| THIAZOLIINEDIONE-BASED REGIMEN | 1 | 1 | 2 | 4 |
| OTHER REGIMEN | 7 | 7 | 7 | 21 |
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