Phase 2
N=70
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01498185 ↗Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Feb 2017
Primary outcome: Primary: Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7 — -16.52; -19.01; -17.29; -23.40 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dapagliflozin (Drug); Placebo matching Dapagliflozin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7 |
-16.52; -19.01; -17.29; -23.40; -17.55 | — |
| SECONDARY Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax) |
12.18; 24.19; 66.11; 134.34 | — |
| SECONDARY Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax) |
1.04; 1.08; 1.03; 1.27 | — |
| SECONDARY Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) |
48.42; 127.17; 269.09; 600.01 | — |
| SECONDARY Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax) |
10.58; 21.96; 49.22; 106.68 | — |
| SECONDARY Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax) |
1.42; 1.83; 1.57; 1.84 | — |
| SECONDARY Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) |
49.63; 132.38; 262.58; 567.77 | — |
| SECONDARY Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU] |
0.72; 0.73; 0.68; 0.66 | — |
Summary
To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%
- Insulin use for at least 12 months and initiation immediately after diagnosis of diabetes
- Method of Insulin administration [multiple daily injections (MDI) or continuous subcutaneous Insulin infusion (CSII)] stable ≥ 3 months
- Stable basal Insulin dose ≥ 2 weeks
- Ages 18 to 65 years
- Central laboratory C-peptide value of 2X Upper limit of normal (ULN)
- Abnormal Free T4 [if screening Thyroid Stimulating Hormone (TSH) abnormal]
- Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) formula ≤ 60 mL/min/1.73m2
- Cardiovascular (CV)/Vascular Diseases within 6 months
Data sourced from ClinicalTrials.gov (NCT01498185). 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.