Trial · NCT00680745

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

NCT00680745, Phase 3, Completed, AstraZeneca; results first posted 2013-10-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients. Trials, record NCT00680745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680745

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Trial

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

Title: Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
NCT number: NCT00680745
Status: Completed
Phases: Phase 3
Enrollment: 597 participants, actual
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes
Interventions: dapagliflozin, Glimepiride, metformin hydrochloride, pioglitazone hydrochloride, Rosiglitazone
First posted: 2008-05-20
Last updated: 2013-10-14
Results first posted: 2013-10-14
Limitations and caveats: For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adjusted Mean Change in HbA1c Levels	Baseline to Week 24	To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
Secondary	Adjusted Mean Change in Body Weight	Baseline to Week 24	To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.
Secondary	Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise	Baseline to Week 24	To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.
Secondary	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%	At Week 24	To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c \< 7% after 24 weeks of treatment, compared to placebo plus glimepiride.
Secondary	Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2	Baseline to Week 24	To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.
Secondary	Adjusted Mean Change in Fasting Plasma Glucose (FPG)	Baseline to Week 24	To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adjusted Mean Change in HbA1c Levels	Baseline to Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	Percent	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Change in Body Weight	Baseline to Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	kg	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise	Baseline to Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%	At Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	Percentage of participants	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2	Baseline to Week 24	Full Analysis Set, participants with baseline BMI of 27 kg/m2 or more and Week 24 (LOCF) body weight value	kg	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Change in Fasting Plasma Glucose (FPG)	Baseline to Week 24	Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Adjusted Mean Change in HbA1c Levels	Dapagliflozin 2.5mg + Glimepiride	-0.58	95% Confidence Interval -0.69 to -0.46	Percent
Adjusted Mean Change in HbA1c Levels	Dapagliflozin 5mg + Glimepiride	-0.63	95% Confidence Interval -0.75 to -0.50	Percent
Adjusted Mean Change in HbA1c Levels	Dapagliflozin 10mg + Glimepiride	-0.82	95% Confidence Interval -0.94 to -0.70	Percent
Adjusted Mean Change in HbA1c Levels	Placebo + Glimepiride	-0.13	95% Confidence Interval -0.26 to -0.01	Percent
Adjusted Mean Change in Body Weight	Dapagliflozin 2.5mg + Glimepiride	-1.18	95% Confidence Interval -1.62 to -0.75	kg
Adjusted Mean Change in Body Weight	Dapagliflozin 5mg + Glimepiride	-1.56	95% Confidence Interval -2.01 to -1.11	kg
Adjusted Mean Change in Body Weight	Dapagliflozin 10mg + Glimepiride	-2.26	95% Confidence Interval -2.70 to -1.83	kg
Adjusted Mean Change in Body Weight	Placebo + Glimepiride	-0.72	95% Confidence Interval -1.16 to -0.28	kg
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise	Dapagliflozin 2.5mg + Glimepiride	-37.5	95% Confidence Interval -46.7 to -28.3	mg/dL
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise	Dapagliflozin 5mg + Glimepiride	-32.0	95% Confidence Interval -41.5 to -22.5	mg/dL

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dapagliflozin 2.5mg + Glimepiride	154
Overall Study	STARTED	Dapagliflozin 5mg + Glimepiride	145
Overall Study	STARTED	Dapagliflozin 10mg + Glimepiride	151
Overall Study	STARTED	Placebo + Glimepiride	146
Overall Study	COMPLETED	Dapagliflozin 2.5mg + Glimepiride	140
Overall Study	COMPLETED	Dapagliflozin 5mg + Glimepiride	132
Overall Study	COMPLETED	Dapagliflozin 10mg + Glimepiride	141
Overall Study	COMPLETED	Placebo + Glimepiride	133
Overall Study	NOT COMPLETED	Dapagliflozin 2.5mg + Glimepiride	14
Overall Study	NOT COMPLETED	Dapagliflozin 5mg + Glimepiride	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events172

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	NASOPHARYNGITIS	Infections and infestations	Dapagliflozin 2.5mg + Glimepiride	3	154
other	NASOPHARYNGITIS	Infections and infestations	Dapagliflozin 5mg + Glimepiride	8	145
other	NASOPHARYNGITIS	Infections and infestations	Dapagliflozin 10mg + Glimepiride	5	151
other	NASOPHARYNGITIS	Infections and infestations	Placebo + Glimepiride	4	146
other	HYPERTENSION	Vascular disorders	Dapagliflozin 2.5mg + Glimepiride	8	154
other	HYPERTENSION	Vascular disorders	Dapagliflozin 5mg + Glimepiride	2	145
other	HYPERTENSION	Vascular disorders	Dapagliflozin 10mg + Glimepiride	2	151
other	HYPERTENSION	Vascular disorders	Placebo + Glimepiride	6	146
other	Hypoglycemia	Endocrine disorders	Dapagliflozin 2.5mg + Glimepiride	11	154
other	Hypoglycemia	Endocrine disorders	Dapagliflozin 5mg + Glimepiride	10	145

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dapagliflozin 2.5mg + Glimepiride
Total, all-cause mortality	Dapagliflozin 5mg + Glimepiride
Total, all-cause mortality	Dapagliflozin 10mg + Glimepiride
Total, all-cause mortality	Placebo + Glimepiride
Total, other adverse events	Dapagliflozin 2.5mg + Glimepiride	22	154
Total, other adverse events	Dapagliflozin 5mg + Glimepiride	19	145
Total, other adverse events	Dapagliflozin 10mg + Glimepiride	18	151
Total, other adverse events	Placebo + Glimepiride	15	146
Total, serious adverse events	Dapagliflozin 2.5mg + Glimepiride	11	154
Total, serious adverse events	Dapagliflozin 5mg + Glimepiride	10	145

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21672123	DERIVED	PubMed
23529567	DERIVED	PubMed
33368935	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.

GET https://conductscience.org/api/trials/v1/NCT00680745

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