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Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Phase 3 trial testing Dapagliflozin in Type 1 Diabetes Mellitus in 815 participants. Completed in 18 April 2018.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 815 |
| Start date | 8 July 2015 |
| Primary completion | 2 September 2017 |
| Estimated completion | 18 April 2018 |
| Sites | 136 locations across Japan, Netherlands, Russia, Belgium, Chile, Sweden, United Kingdom, Germany |
AstraZeneca — full company profile →
Adults 18 to 75, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | -0.34 | -0.43 – -0.25 |
| DAPA 10 MG + INS | -0.39 | -0.48 – -0.30 |
| PLA + INS | 0.03 | -0.06 – 0.12 |
To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | -8.73 | -11.09 – -6.31 |
| DAPA 10 MG + INS | -9.05 | -11.43 – -6.60 |
| PLA + INS | 2.29 | -0.41 – 5.06 |
To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | -3.22 | -3.76 – -2.69 |
| DAPA 10 MG + INS | -3.76 | -4.29 – -3.22 |
| PLA + INS | -0.02 | -0.57 – 0.54 |
To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | -6.46 | -10.04 – -2.87 |
| DAPA 10 MG + INS | -10.54 | -14.14 – -6.94 |
| PLA + INS | 9.20 | 5.57 – 12.83 |
To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | -10.17 | -13.90 – -6.45 |
| DAPA 10 MG + INS | -9.68 | -13.44 – -5.93 |
| PLA + INS | -0.33 | -4.12 – 3.46 |
To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of \>70 mg/dL and \<=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | 5.92 | 4.32 – 7.52 |
| DAPA 10 MG + INS | 7.60 | 5.98 – 9.21 |
| PLA + INS | -3.10 | -4.73 – -1.47 |
To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit \>=0.5% without severe hypoglycemia events
| Group | Value | 95% CI |
|---|---|---|
| DAPA 5 MG + INS | 105 | |
| DAPA 10 MG + INS | 111 | |
| PLA + INS | 54 |
Time frame: All adverse events (AEs), including serious adverse events (SAEs), were collected from the time informed consent was signed throughout the treatment period (through week 24).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | DAPA 5 MG + INS | DAPA 10 MG + INS | PLA + INS |
|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | — | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — | — |
| Hypoglycaemic seizure | Nervous system disorders | — | — | — |
| Ketoacidosis | Metabolism and nutrition disorders | — | — | — |
| Ketosis | Metabolism and nutrition disorders | — | — | — |
| Lactic acidosis | Metabolism and nutrition disorders | — | — | — |
| Cerebral haemorrhage | Nervous system disorders | — | — | — |
| Coma | Nervous system disorders | — | — | — |
| Diabetic hyperglycaemic coma | Nervous system disorders | — | — | — |
| Seizure | Nervous system disorders | — | — | — |
| Cerebral infarction | Nervous system disorders | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — |
| Hypoglycaemic coma | Nervous system disorders | — | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — | — |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | — | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — |
| Enteritis | Gastrointestinal disorders | — | — | — |
| Chest pain | General disorders | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Cellulitis | Infections and infestations | — | — | — |
| Labyrinthitis | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Reaction | System | DAPA 5 MG + INS | DAPA 10 MG + INS | PLA + INS |
|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | — | — | — |
| Pollakiuria | Renal and urinary disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Thirst | General disorders | — | — | — |
Most-reported serious reactions: Diabetic ketoacidosis, Hypoglycemia, Hypoglycaemic seizure, Ketoacidosis, Ketosis, Lactic acidosis, Cerebral haemorrhage, Coma.
Data from ClinicalTrials.gov NCT02460978 adverse events section.
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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