Trial · NCT00313313

A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

NCT00313313, Phase 3, Completed, AstraZeneca; results first posted 2009-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas. Trials, record NCT00313313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00313313

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
NCT number: NCT00313313
Status: Completed
Phases: Phase 3
Enrollment: 768 participants, actual
Lead sponsor: AstraZeneca
Conditions: Diabetes
Interventions: Saxagliptin, Saxagliptin, Glyburide, Placebo, Glyburide, Metformin
First posted: 2006-04-12
Last updated: 2015-05-04
Results first posted: 2009-09-25

Source ClinicalTrials.gov

Registered outcomes4

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	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	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	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.
Secondary	Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24	Baseline, Week 24	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.

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	Change From Baseline in Hemoglobin A1c (A1C) at Week 24	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), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.	percent	MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	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	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	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

Source ClinicalTrials.gov

Results by group30

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 2.5 mg + Glyburide 7.5 mg	Baseline Mean	8.36	Standard Error 0.057	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Saxagliptin 5 mg + Glyburide 7.5 mg	Baseline Mean	8.48	Standard Error 0.056	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Placebo + Glyburide 7.5 mg	Baseline Mean	8.44	Standard Error 0.055	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Saxagliptin 2.5 mg + Glyburide 7.5 mg	Week 24 Mean	7.83	Standard Error 0.074	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Saxagliptin 5 mg + Glyburide 7.5 mg	Week 24 Mean	7.83	Standard Error 0.074	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Placebo + Glyburide 7.5 mg	Week 24 Mean	8.52	Standard Error 0.077	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Saxagliptin 2.5 mg + Glyburide 7.5 mg	Adjusted Mean Change from Baseline	-0.54	Standard Error 0.059	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Saxagliptin 5 mg + Glyburide 7.5 mg	Adjusted Mean Change from Baseline	-0.64	Standard Error 0.059	percent
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Placebo + Glyburide 7.5 mg	Adjusted Mean Change from Baseline	0.08	Standard Error 0.057	percent
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Saxagliptin 2.5 mg + Glyburide 7.5 mg	Baseline Mean	170.1	Standard Error 2.67	mg/dL

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Saxagliptin 2.5 mg + Glyburide 7.5 mg	248
Overall Study	STARTED	Saxagliptin 5 mg + Glyburide 7.5 mg	253
Overall Study	STARTED	Placebo + Glyburide 7.5 mg	267
Overall Study	COMPLETED	Saxagliptin 2.5 mg + Glyburide 7.5 mg	185
Overall Study	COMPLETED	Saxagliptin 5 mg + Glyburide 7.5 mg	187
Overall Study	COMPLETED	Placebo + Glyburide 7.5 mg	185
Overall Study	NOT COMPLETED	Saxagliptin 2.5 mg + Glyburide 7.5 mg	63
Overall Study	NOT COMPLETED	Saxagliptin 5 mg + Glyburide 7.5 mg	66
Overall Study	NOT COMPLETED	Placebo + Glyburide 7.5 mg	82

Source ClinicalTrials.gov

Adverse events183

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
other	HYPERTENSION	Vascular disorders	Placebo + Glyburide 7.5 mg	15	267
other	HYPERTENSION	Vascular disorders	Saxagliptin 2.5 mg + Glyburide 7.5 mg	15	248
other	HYPERTENSION	Vascular disorders	Saxagliptin 5 mg + Glyburide 7.5 mg	23	253
other	HEADACHE	Nervous system disorders	Placebo + Glyburide 7.5 mg	23	267
other	HEADACHE	Nervous system disorders	Saxagliptin 2.5 mg + Glyburide 7.5 mg	23	248
other	HEADACHE	Nervous system disorders	Saxagliptin 5 mg + Glyburide 7.5 mg	25	253
other	DIARRHOEA	Gastrointestinal disorders	Placebo + Glyburide 7.5 mg	27	267
other	DIARRHOEA	Gastrointestinal disorders	Saxagliptin 2.5 mg + Glyburide 7.5 mg	22	248
other	DIARRHOEA	Gastrointestinal disorders	Saxagliptin 5 mg + Glyburide 7.5 mg	16	253
other	DYSPEPSIA	Gastrointestinal disorders	Placebo + Glyburide 7.5 mg	8	267

1 to 10 of 183Source ClinicalTrials.gov

See all 183 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Glyburide 7.5 mg
Total, all-cause mortality	Saxagliptin 2.5 mg + Glyburide 7.5 mg
Total, all-cause mortality	Saxagliptin 5 mg + Glyburide 7.5 mg
Total, other adverse events	Placebo + Glyburide 7.5 mg	163	267
Total, other adverse events	Saxagliptin 2.5 mg + Glyburide 7.5 mg	144	248
Total, other adverse events	Saxagliptin 5 mg + Glyburide 7.5 mg	154	253
Total, serious adverse events	Placebo + Glyburide 7.5 mg	23	267
Total, serious adverse events	Saxagliptin 2.5 mg + Glyburide 7.5 mg	18	248
Total, serious adverse events	Saxagliptin 5 mg + Glyburide 7.5 mg	12	253

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19614786	BACKGROUND	PubMed
21562067	DERIVED	PubMed
21680990	DERIVED	PubMed
23795975	DERIVED	PubMed
27033025	DERIVED	PubMed
27402391	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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