Trial · NCT00666458
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
NCT00666458, Phase 3, Completed, AstraZeneca; results first posted 2010-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D). Trials, record NCT00666458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
- NCT number
- NCT00666458
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 822 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes
- Interventions
- saxagliptin, sitagliptin
- First posted
- 2008-04-25
- Last updated
- 2010-04-15
- Other registries' IDs
- eudract:2007-006095-11
- Results first posted
- 2010-04-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Baseline, 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. |
| Secondary | Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | Week 18 (Last Observation Carried Forward) | Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \<= 6.5% at Week 18 (Full Analysis Set) |
| Secondary | Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) | Baseline, Week 18 (Last Observation Carried Forward) | 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. |
| Secondary | Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) | Baseline, Week 18 (Last Observation Carried Forward) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Baseline, Week 18 | Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations. | Percent | MEAN |
| SECONDARY | Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | Week 18 (Last Observation Carried Forward) | Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement. | Percentage of Participants | NUMBER |
| SECONDARY | Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) | Baseline, Week 18 (Last Observation Carried Forward) | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. | mg/dL | MEAN |
| SECONDARY | Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) | Baseline, Week 18 (Last Observation Carried Forward) | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. | mmol/L | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Saxa + Met | Baseline | 7.68 | Standard Error 0.052 | Percent |
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Sita + Met | Baseline | 7.69 | Standard Error 0.047 | Percent |
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Saxa + Met | Week 18 | 7.16 | Standard Error 0.052 | Percent |
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Sita + Met | Week 18 | 7.07 | Standard Error 0.051 | Percent |
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Saxa + Met | Adjusted Change from Baseline | -0.52 | Standard Error 0.039 | Percent |
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Sita + Met | Adjusted Change from Baseline | -0.62 | Standard Error 0.038 | Percent |
| Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | Saxa + Met | 26.3 | Percentage of Participants | ||
| Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | Sita + Met | 29.1 | Percentage of Participants | ||
| Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) | Saxa + Met | Baseline | 159.67 | Standard Error 2.280 | mg/dL |
| Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) | Sita + Met | Baseline | 160.22 | Standard Error 2.192 | mg/dL |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saxa + Met | 403 | |
| Overall Study | STARTED | Sita + Met | 398 | |
| Overall Study | COMPLETED | Saxa + Met | 365 | |
| Overall Study | COMPLETED | Sita + Met | 374 | |
| Overall Study | NOT COMPLETED | Saxa + Met | 38 | |
| Overall Study | NOT COMPLETED | Sita + Met | 24 |
Source ClinicalTrials.gov
Adverse events28
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 | Urinary Tract Infection | Infections and infestations | Saxa + Met | 28 | 403 | |
| other | Urinary Tract Infection | Infections and infestations | Sita + Met | 26 | 398 | |
| other | Influenza | Infections and infestations | Saxa + Met | 27 | 403 | |
| other | Influenza | Infections and infestations | Sita + Met | 27 | 398 | |
| serious | Chills | General disorders | Saxa + Met | 1 | 403 | |
| serious | Chills | General disorders | Sita + Met | 0 | 398 | |
| serious | Ulcer Haemorrhage | General disorders | Saxa + Met | 1 | 403 | |
| serious | Ulcer Haemorrhage | General disorders | Sita + Met | 0 | 398 | |
| serious | Supraventricular Tachycardia | Cardiac disorders | Saxa + Met | 1 | 403 | |
| serious | Supraventricular Tachycardia | Cardiac disorders | Sita + Met | 1 | 398 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saxa + Met | ||
| Total, all-cause mortality | Sita + Met | ||
| Total, other adverse events | Saxa + Met | 54 | 403 |
| Total, other adverse events | Sita + Met | 50 | 398 |
| Total, serious adverse events | Saxa + Met | 7 | 403 |
| Total, serious adverse events | Sita + Met | 5 | 398 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Saxa + Met vs Sita + Met: serious adverse events |
Source Trial comparisons
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/NCT00666458
GET https://conductscience.org/api/trials/v1/NCT00666458/events?page=2