A Phase 3 interventional study of saxagliptin and sitagliptin in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 86 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-15.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 822 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 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:
saxagliptin add-on to metformin
Drug: saxagliptin
sitagliptin add-on to metformin
Drug: sitagliptin
tablet, per oral, once daily
Also known as: Onglyza
capsule, per oral, once daily
Also known as: Januvia
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Time frame: Baseline, Week 18
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \<= 6.5% at Week 18 (Full Analysis Set)
Time frame: Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Time frame: Baseline, Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Time frame: Baseline, Week 18 (Last Observation Carried Forward)
| Milestone | Saxa + Met | Sita + Met |
|---|---|---|
| Started | 403 | 398 |
| Completed | 365 | 374 |
| Not completed | 38 | 24 |
| Withdrew: Adverse event | 8 | 7 |
| Withdrew: Withdrawal by subject | 5 | 4 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Administrative reason by sponsor | 1 | 1 |
| Withdrew: Incorrect enrollment | 7 | 1 |
| Withdrew: Study specific discontinuation criteria | 14 | 7 |
| Withdrew: Severe non-compliance to the protocol | 1 | 1 |
| Withdrew: Safety reasons | 1 | 0 |
| Withdrew: Medical history of anemia | 1 | 0 |
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
| Percent | Saxa + Met | Sita + Met |
|---|---|---|
| Baseline | 7.68 ± 0.052 | 7.69 ± 0.047 |
| Week 18 | 7.16 ± 0.052 | 7.07 ± 0.051 |
| Adjusted Change from Baseline | -0.52 ± 0.039 | -0.62 ± 0.038 |
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \<= 6.5% at Week 18 (Full Analysis Set)
| Percentage of Participants | Saxa + Met | Sita + Met |
|---|---|---|
| Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | 26.3 | 29.1 |
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
| mg/dL | Saxa + Met | Sita + Met |
|---|---|---|
| Baseline | 159.67 ± 2.280 | 160.22 ± 2.192 |
| Week 18 | 149.04 ± 1.991 | 143.94 ± 1.864 |
| Adjusted Change from Baseline | -10.75 ± 1.455 | -16.16 ± 1.464 |
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
| mmol/L | Saxa + Met | Sita + Met |
|---|---|---|
| Baseline | 8.86 ± 0.127 | 8.89 ± 0.122 |
| Week 18 | 8.27 ± 0.111 | 7.99 ± 0.103 |
| Adjusted Change from Baseline | -0.60 ± 0.081 | -0.90 ± 0.081 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saxa + Met | — | 7/403 (1.7%) | 54/403 (13.4%) |
| Sita + Met | — | 5/398 (1.3%) | 50/398 (12.6%) |
| Event | Saxa + Met | Sita + Met |
|---|---|---|
| Supraventricular TachycardiaCardiac disorders | 1/403 | 1/398 |
| FallInjury, poisoning and procedural complications | 0/403 | 1/398 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/403 | 1/398 |
| Hypoglycaemic UnconsciousnessMetabolism and nutrition disorders | 0/403 | 1/398 |
| Aortic AneurysmVascular disorders | 0/403 | 1/398 |
| ChillsGeneral disorders | 1/403 | 0/398 |
| Ulcer HaemorrhageGeneral disorders | 1/403 | 0/398 |
| FaecalomaGastrointestinal disorders | 1/403 | 0/398 |
| ROAD TRAFFIC ACCIDENTInjury, poisoning and procedural complications | 1/403 | 0/398 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/403 | 0/398 |
| Event | Saxa + Met | Sita + Met |
|---|---|---|
| Urinary Tract InfectionInfections and infestations | 28/403 | 26/398 |
| InfluenzaInfections and infestations | 27/403 | 27/398 |
| Age Continuous(years) | Saxa + Met | Sita + Met | Total |
|---|---|---|---|
| Mean | 58.77 ± 10.14 | 58.07 ± 10.51 | 58.42 ± 10.32 |
| Sex: Female, Male(Participants) | Saxa + Met | Sita + Met | Total |
|---|---|---|---|
| Female | 213 | 196 | 409 |
| Male | 190 | 202 | 392 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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