Phase 3
N=813
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02460978 ↗Enrolled (actual)
813
Serious AEs
3.7%
Results posted
Nov 2018
Primary outcome: Primary: Adjusted Mean Change From Baseline in HbA1c at Week 24 — -0.34; -0.39; 0.03 HbA1c (%) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dapagliflozin (Drug); Placebo for dapagliflozin (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in HbA1c at Week 24 |
-0.34; -0.39; 0.03 | <0.0001 sig |
| SECONDARY Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24 |
-8.73; -9.05; 2.29 | <0.0001 sig |
| SECONDARY Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24 |
-3.22; -3.76; -0.02 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24 |
-6.46; -10.54; 9.20 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24 |
-10.17; -9.68; -0.33 | <0.0001 sig |
| SECONDARY 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 (%) at Week 24 |
5.92; 7.60; -3.10 | <0.0001 sig |
| SECONDARY Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24 |
105; 111; 54 | <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 any non-insulin antihyperglicemic agent 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
- Taking metformin and/or thiazolidinediones within 2 months prior to screening
- 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 (NCT02460978). 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.