Phase 3
N=833
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02268214 ↗Enrolled (actual)
833
Serious AEs
12.9%
Results posted
Mar 2018
Primary outcome: Primary: Adjusted Mean Change in HbA1c From Baseline at Week 24 — -0.45; -0.47; -0.03 Percentage of hemoglobin — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dapagliflozin (Drug); Placebo for dapagliflozin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c From Baseline at Week 24 |
-0.45; -0.47; -0.03 | <0.0001 sig |
| SECONDARY Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24 |
-7.74; -12.16; 1.16 | <0.0001 sig |
| SECONDARY Adjusted Mean Percent Change in Body Weight From Baseline at Week 24 |
-3.00; -3.67; 0.05 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24 |
-10.28; -12.97; 5.06 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24 |
-14.92; -16.55; 2.38 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24 |
6.98; 8.52; -2.13 | <0.0001 sig |
| SECONDARY Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events |
127; 129; 65 | <0.0001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Type 1 Diabetes mellitus (T1DM)
- Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)
- Insulin use for at least 12 months per patient reported or medical records
- Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
- Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
- If on MDI insulin administration, subject must be on ≥ 3x injections per day
- Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
- Body mass index (BMI) ≥ 18.5 kg/m2
Exclusion Criteria
- History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
- Taking metformin and/or thiazolidinediones within 2 months prior to screening
- Taking any antidiabetic medication (other than insulin), within 1 month prior to screening
- Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
- History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
- History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
- Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
- History of Addison's disease
Data sourced from ClinicalTrials.gov (NCT02268214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.