Trial · NCT00327015
A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
NCT00327015, Phase 3, Completed, AstraZeneca; results first posted 2009-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise. Trials, record NCT00327015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00327015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
- NCT number
- NCT00327015
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,306 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Diabetes
- Interventions
- Saxagliptin, Saxagliptin, Metformin, Placebo, pioglitazone
- First posted
- 2006-05-17
- Last updated
- 2015-04-29
- Results first posted
- 2009-09-25
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Mean change from baseline in A1C at Week 24, adjusted for baseline value. |
| Primary | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Mean change from baseline in A1C at Week 24, adjusted for baseline value. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Mean change from baseline in FPG at Week 24, adjusted for baseline value. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Mean change from baseline in FPG at Week 24, adjusted for baseline value. |
| Secondary | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. |
| Secondary | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. |
| Secondary | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. |
| Secondary | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. |
| Secondary | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. |
| Secondary | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue. | percent | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | Percentage of participants | NUMBER |
| SECONDARY | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | mg*min/dL | MEAN |
| PRIMARY | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | percent | MEAN |
| SECONDARY | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | mg*min/dL | MEAN |
| SECONDARY | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 5 mg + Metformin | Baseline Mean | 9.41 | Standard Error 0.072 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 10 mg + Metformin | Baseline Mean | 9.53 | Standard Error 0.069 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 10 mg | Baseline Mean | 9.61 | Standard Error 0.075 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 5 mg + Metformin | Week 24 Mean | 6.93 | Standard Error 0.066 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 10 mg + Metformin | Week 24 Mean | 7.02 | Standard Error 0.067 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 10 mg | Week 24 Mean | 7.86 | Standard Error 0.085 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 5 mg + Metformin | Adjusted Mean Change from Baseline | -2.53 | Standard Error 0.070 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 10 mg + Metformin | Adjusted Mean Change from Baseline | -2.49 | Standard Error 0.069 | percent |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 10 mg | Adjusted Mean Change from Baseline | -1.69 | Standard Error 0.069 | percent |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Saxagliptin 5 mg + Metformin | Baseline Mean | 198.9 | Standard Error 3.17 | mg/dL |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saxagliptin 5 mg + Metformin | 320 | |
| Overall Study | STARTED | Saxagliptin 10 mg + Metformin | 323 | |
| Overall Study | STARTED | Saxagliptin 10 mg | 335 | |
| Overall Study | STARTED | Metformin | 328 | |
| Overall Study | Completed Study Without Being Rescued | Saxagliptin 5 mg + Metformin | 179 | |
| Overall Study | Completed Study Without Being Rescued | Saxagliptin 10 mg + Metformin | 177 | |
| Overall Study | Completed Study Without Being Rescued | Saxagliptin 10 mg | 113 | |
| Overall Study | Completed Study Without Being Rescued | Metformin | 144 | |
| Overall Study | COMPLETED | Saxagliptin 5 mg + Metformin | 229 | |
| Overall Study | COMPLETED | Saxagliptin 10 mg + Metformin | 231 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events308
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HYPERTENSION | Vascular disorders | Metformin | 17 | 328 | |
| other | HYPERTENSION | Vascular disorders | Saxagliptin 10 mg | 19 | 335 | |
| other | HYPERTENSION | Vascular disorders | Saxagliptin 10 mg + Metformin | 21 | 323 | |
| other | HYPERTENSION | Vascular disorders | Saxagliptin 5 mg + Metformin | 27 | 320 | |
| other | HEADACHE | Nervous system disorders | Metformin | 18 | 328 | |
| other | HEADACHE | Nervous system disorders | Saxagliptin 10 mg | 31 | 335 | |
| other | HEADACHE | Nervous system disorders | Saxagliptin 10 mg + Metformin | 36 | 323 | |
| other | HEADACHE | Nervous system disorders | Saxagliptin 5 mg + Metformin | 31 | 320 | |
| other | DIARRHOEA | Gastrointestinal disorders | Metformin | 30 | 328 | |
| other | DIARRHOEA | Gastrointestinal disorders | Saxagliptin 10 mg | 12 | 335 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | ||
| Total, all-cause mortality | Saxagliptin 10 mg | ||
| Total, all-cause mortality | Saxagliptin 10 mg + Metformin | ||
| Total, all-cause mortality | Saxagliptin 5 mg + Metformin | ||
| Total, other adverse events | Metformin | 106 | 328 |
| Total, other adverse events | Saxagliptin 10 mg | 106 | 335 |
| Total, other adverse events | Saxagliptin 10 mg + Metformin | 122 | 323 |
| Total, other adverse events | Saxagliptin 5 mg + Metformin | 116 | 320 |
| Total, serious adverse events | Metformin | 15 | 328 |
| Total, serious adverse events | Saxagliptin 10 mg | 16 | 335 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00327015
GET https://conductscience.org/api/trials/v1/NCT00327015/results?page=2