A Phase 3 interventional study of Saxagliptin and Saxagliptin in Diabetes, sponsored by AstraZeneca. Completed at 115 sites in 13 countries. Open to participants aged 18 Years to 77 Years. Per ClinicalTrials.gov, last updated 2015-05-04.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 768 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.
Inclusion Criteria:
Metformin 500-2500 mg (as needed)
Drug: Saxagliptin · Drug: Glyburide · Drug: Metformin
Metformin 500-2500 mg (as needed)
Drug: Saxagliptin · Drug: Glyburide · Drug: Metformin
Metformin 500-2500 mg (as needed)
Drug: Placebo · Drug: Glyburide · Drug: Metformin
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])
Also known as: BMS-477118
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Also known as: BMS-477118
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.
Time frame: Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.
Time frame: Baseline, Week 24
| Milestone | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg |
|---|---|---|---|
| Started | 248 | 253 | 267 |
| Completed | 185 | 187 | 185 |
| Not completed | 63 | 66 | 82 |
| Withdrew: Lack of efficacy | 14 | 9 | 20 |
| Withdrew: Withdrawal of consent by subject | 18 | 17 | 31 |
| Withdrew: Lost to follow-up | 10 | 7 | 9 |
| Withdrew: Adverse event | 15 | 16 | 12 |
| Withdrew: Physician decision | 2 | 6 | 4 |
| Withdrew: Poor/noncompliance | 3 | 6 | 2 |
| Withdrew: Pregnancy | 1 | 2 | 0 |
| Withdrew: Death | 0 | 0 | 2 |
| Withdrew: Subject no longer meets study criteria | 0 | 3 | 2 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
| percent | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg |
|---|---|---|---|
| Baseline Mean | 8.36 ± 0.057 | 8.48 ± 0.056 | 8.44 ± 0.055 |
| Week 24 Mean | 7.83 ± 0.074 | 7.83 ± 0.074 | 8.52 ± 0.077 |
| Adjusted Mean Change from Baseline | -0.54 ± 0.059 | -0.64 ± 0.059 | 0.08 ± 0.057 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
| mg/dL | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg |
|---|---|---|---|
| Baseline Mean | 170.1 ± 2.67 | 175.0 ± 2.79 | 174.4 ± 2.64 |
| Week 24 Mean | 164.4 ± 2.76 | 164.6 ± 2.76 | 174.6 ± 2.93 |
| Adjusted Mean Change from Baseline | -7.1 ± 2.42 | -9.7 ± 2.39 | 0.7 ± 2.33 |
Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.
| Percentage of participants | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg |
|---|---|---|---|
| Percentage of Participants Achieving A1C < 7% at Week 24 | 22.4 | 22.8 | 9.1 |
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.
| mg*min/dL | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg |
|---|---|---|---|
| Baseline Mean | 49124 ± 677.2 | 50342 ± 669.0 | 51801 ± 656.9 |
| Week 24 Mean | 45402 ± 681.5 | 45391 ± 699.3 | 52416 ± 703.7 |
| Adjusted Mean Change from Baseline | -4296 ± 595.0 | -5000 ± 585.5 | 1196 ± 574.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Glyburide 7.5 mg | — | 23/267 (8.6%) | 163/267 (61%) |
| Saxagliptin 2.5 mg + Glyburide 7.5 mg | — | 18/248 (7.3%) | 144/248 (58.1%) |
| Saxagliptin 5 mg + Glyburide 7.5 mg | — | 12/253 (4.7%) | 154/253 (60.9%) |
| Event | Placebo + Glyburide 7.5 mg | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg |
|---|---|---|---|
| PNEUMONIAInfections and infestations | 3/267 | 0/248 | 0/253 |
| NEPHROLITHIASISRenal and urinary disorders | 3/267 | 0/248 | 0/253 |
| MYOCARDIAL ISCHAEMIACardiac disorders | 0/267 | 2/248 | 0/253 |
| APPENDICITISInfections and infestations | 0/267 | 2/248 | 0/253 |
| CHEST PAINGeneral disorders | 0/267 | 2/248 | 0/253 |
| CHOLECYSTITIS ACUTEHepatobiliary disorders | 0/267 | 0/248 | 2/253 |
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 2/267 | 1/248 | 1/253 |
| CORONARY ARTERY DISEASECardiac disorders | 1/267 | 1/248 | 0/253 |
| CEREBROVASCULAR ACCIDENTNervous system disorders | 1/267 | 1/248 | 0/253 |
| ASCITESGastrointestinal disorders | 0/267 | 1/248 | 0/253 |
| Event | Placebo + Glyburide 7.5 mg | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg |
|---|---|---|---|
| URINARY TRACT INFECTIONInfections and infestations | 32/267 | 33/248 | 42/253 |
| NASOPHARYNGITISInfections and infestations | 29/267 | 21/248 | 26/253 |
| DIARRHOEAGastrointestinal disorders | 27/267 | 22/248 | 16/253 |
| INFLUENZAInfections and infestations | 27/267 | 21/248 | 19/253 |
| HEADACHENervous system disorders | 23/267 | 23/248 | 25/253 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 25/267 | 17/248 | 24/253 |
| HYPERTENSIONVascular disorders | 15/267 | 15/248 | 23/253 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 20/267 | 18/248 | 20/253 |
| COUGHRespiratory, thoracic and mediastinal disorders | 17/267 | 19/248 | 15/253 |
| PHARYNGITISInfections and infestations | 15/267 | 11/248 | 19/253 |
| Age, Continuous(years) | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg | Total |
|---|---|---|---|---|
| Mean | 55.36 ± 9.58 | 54.85 ± 9.96 | 55.06 ± 10.69 | 55.09 ± 10.09 |
| Sex: Female, Male(Participants) | Saxagliptin 2.5 mg + Glyburide 7.5 mg | Saxagliptin 5 mg + Glyburide 7.5 mg | Placebo + Glyburide 7.5 mg | Total |
|---|---|---|---|---|
| Female | 135 | 143 | 144 | 422 |
| Male | 113 | 110 | 123 | 346 |
Showing the first 100 of 115 sites across 13 countries.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca