Phase 3
N=272
Phase III Insulin Add-On Asia Regional Program - ST
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02096705 ↗Enrolled (actual)
272
Serious AEs
9.6%
Results posted
Mar 2017
Primary outcome: Primary: Adjusted Mean Change in HbA1c From Baseline to Week 24 — 0.03; -0.87 percentage of hemoglobin — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dapagliflozin (Drug); Dapagliflozin Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c From Baseline to Week 24 |
0.03; -0.87 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 |
0.07; -30.62 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight From Baseline to Week 24 |
0.37; -1.00 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24 |
0.74; -0.70 | 0.0059 sig |
Summary
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
- Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
Inclusion criteria for randomization:
HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
Exclusion Criteria
- Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
- History of diabetic ketoacidosis of hyperosmolar nonketotic coma
- Clinically diagnosed Type 1 diabetes mellitus
- Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
- Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
- History of unstable or rapidly progressing renal disease
- History of severe hepatobiliary disease
- Mallingancy within 5 years of the screening/enrollment visit
Data sourced from ClinicalTrials.gov (NCT02096705). 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.