Trial · NCT02547935
A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
NCT02547935, Phase 2, Phase 3, Completed, AstraZeneca; results first posted 2019-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD. Trials, record NCT02547935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02547935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
- NCT number
- NCT02547935
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 459 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes Mellitus, CKD and Albuminuria
- Interventions
- Dapagliflozin 10 mg, Saxagliptin 2.5 mg, Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
- First posted
- 2015-09-14
- Last updated
- 2019-08-21
- Results first posted
- 2019-06-04
- Limitations and caveats
Anomalous data at 1 site was identified following completion of the study. All data from this site were excluded from the full analysis following an audit; the findings led the sponsor to believe the site did not comply with the principles of GCP.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 | Baseline and Week 24 | HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model. |
| Primary | Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 | Baseline and Week 24 | UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24. |
| Secondary | Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24 | Baseline and Week 24 | Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24. |
| Secondary | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | FPG was analysed at baseline and Week 1 then every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model. |
| Secondary | Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24 | From baseline up to Week 24 | The percentage of patients meeting the criteria of at least a 30% reduction in UACR, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (Last Observation Carried Forward \[LOCF\]). |
| Secondary | Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24 | From baseline to Week 24 | The percentage of patients meeting the criteria of a less than 7% reduction in HbA1c, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (LOCF). Only measurements prior to rescue or treatment discontinuation were analysed. |
| Secondary | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24 | Baseline and Week 24 | Seated SBP was analysed at baseline, Week 1 and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model. |
| Secondary | Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24 | Baseline and Week 24 | HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 | Baseline and Week 24 | Patients from the Full Analysis Set (all randomised patients who took at least 1 dose of double-blind study drug and had a non missing baseline value and at least one post-baseline efficacy variable value) with non-missing baseline and Week 24 values for HbA1c. | Percentage of Glycoslyated HbA1c | LEAST_SQUARES_MEAN |
| PRIMARY | Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 | Baseline and Week 24 | Patients from the Full Analysis Set with non-missing baseline and Week 24 values for UACR. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24 | Baseline and Week 24 | Patients from the Full Analysis Set with non-missing baseline and Week 24 values for total body weight. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline and Week 24 | Patients from the Full Analysis Set with non-missing baseline and Week 24 values for FPG. | mg/decilitre (dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24 | From baseline up to Week 24 | Patients from the Full Analysis Set with non-missing baseline and at least one post-baseline UACR value. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24 | From baseline to Week 24 | Patients from the Full Analysis Set with non-missing baseline and at least one post-baseline HbA1c value. | Percentage of patients | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24 | Baseline and Week 24 | Patients from the Full Analysis Set with non-missing baseline and Week 24 values for SBP. | Millimetre of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24 | Baseline and Week 24 | Patients from the Full Analysis Set with non-missing baseline and Week 24 values for HbA1c. | Percentage of Glycoslyated HbA1c | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | -0.85 | Standard Error 0.09 | Percentage of Glycoslyated HbA1c | |
| Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 | Placebo | -0.27 | Standard Error 0.09 | Percentage of Glycoslyated HbA1c | |
| Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | -39.1 | Standard Error 5.1 | Percent change | |
| Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 | Dapagliflozin 10 mg | -22.4 | Standard Error 6.6 | Percent change | |
| Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 | Placebo | -1.8 | Standard Error 8.3 | Percent change | |
| Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24 | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | -0.65 | Standard Error 0.55 | Percent change | |
| Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24 | Dapagliflozin 10 mg | -1.48 | Standard Error 0.56 | Percent change | |
| Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24 | Placebo | -0.61 | Standard Error 0.56 | Percent change | |
| Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | -17.2 | Standard Error 5.2 | mg/decilitre (dL) | |
| Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Dapagliflozin 10 mg | -13.1 | Standard Error 5.4 | mg/decilitre (dL) |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 155 | |
| Overall Study | STARTED | Dapagliflozin 10 mg | 145 | |
| Overall Study | STARTED | Placebo | 148 | |
| Overall Study | Received Treatment | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 152 | |
| Overall Study | Received Treatment | Dapagliflozin 10 mg | 145 | |
| Overall Study | Received Treatment | Placebo | 148 | |
| Overall Study | Full Analysis Set | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 152 | |
| Overall Study | Full Analysis Set | Dapagliflozin 10 mg | 144 | |
| Overall Study | Full Analysis Set | Placebo | 148 | |
| Overall Study | Safety Analysis Set | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 152 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events126
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 | Influenza | Infections and infestations | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 2 | 152 | 2 |
| other | Influenza | Infections and infestations | Dapagliflozin 10 mg | 8 | 145 | 8 |
| other | Influenza | Infections and infestations | Placebo | 2 | 148 | 2 |
| other | Nasopharyngitis | Infections and infestations | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 10 | 152 | 12 |
| other | Nasopharyngitis | Infections and infestations | Dapagliflozin 10 mg | 10 | 145 | 11 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 148 | 6 |
| serious | Anaemia | Blood and lymphatic system disorders | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 0 | 152 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Dapagliflozin 10 mg | 0 | 145 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 148 | 1 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 1 | 152 | 1 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 1 | 152 |
| Total, all-cause mortality | Dapagliflozin 10 mg | 1 | 145 |
| Total, all-cause mortality | Placebo | 0 | 148 |
| Total, other adverse events | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 12 | 152 |
| Total, other adverse events | Dapagliflozin 10 mg | 18 | 145 |
| Total, other adverse events | Placebo | 8 | 148 |
| Total, serious adverse events | Dapagliflozin 10 mg + Saxagliptin 2.5 mg | 12 | 152 |
| Total, serious adverse events | Dapagliflozin 10 mg | 12 | 145 |
| Total, serious adverse events | Placebo | 16 | 148 |
Source ClinicalTrials.gov
Papers3
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.
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