Phase 1
Completed N=42
Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants
Source: ClinicalTrials.gov NCT01662999 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population — 133; 125 ng/mL
Summary
The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population |
133; 125 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population |
547; 539 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin |
529; 523 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population |
23.6; 21.9 | — |
| PRIMARY AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population |
87.8; 87.0 | — |
| PRIMARY AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population |
89.0; 88.2 | — |
| SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population |
1.00; 1.00 | — |
| SECONDARY Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population |
15.9; 13.8 | — |
| SECONDARY Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population |
305; 309 | — |
| SECONDARY Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population |
47.0; 49.6 | — |
| SECONDARY AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population |
267; 289 | — |
| SECONDARY AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population |
273; 296 | — |
| SECONDARY Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population |
138; 137 | — |
| SECONDARY AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population |
702; 735; 694; 727 | — |
| SECONDARY Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population |
0.50; 1.00; 1.50; 1.50; 1.00; 1.00 | — |
| SECONDARY Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population |
5.86; 5.38; 15.9; 17.0 | — |
| SECONDARY Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable |
1.90; 2.16; 2.92; 3.19; 2.89; 3.16 | — |
| SECONDARY Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population |
6; 9; 8; 4; 4; 7 | — |
| SECONDARY Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population |
0; 0; 1; 1; 1; 1 | — |
| SECONDARY Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population |
-6.0; -4.6; -7.2; -2.6; -2.0; -3.3 | — |
| SECONDARY Mean Change From Baseline in Heart Rate - Safety Population |
-4.4; -4.0; -4.3 | — |
| SECONDARY Mean Change From Baseline in Respiration Rate - Safety Population |
-0.4; -1.2; -0.9 | — |
| SECONDARY Mean Change From Baseline in Temperature - Safety Population |
-0.15; -0.23; -0.16 | — |
| SECONDARY Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population |
0; 2; 5; 0; 0; 1 | — |
| SECONDARY Number of Participants With Change From Baseline in ECG Interval - Safety Population |
0; 0; 0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, Physical Examination, vital signs, 12-lead ECG, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 30 kg/m2
- Men and women, ages 18 to 45 years
- Women of childbearing potential must use acceptable methods of highly effective birth control
Exclusion Criteria
- History of chronic or recurrent urinary tract infection for females
- History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose transporter type 2 (SGLT2) inhibitors
- Any significant acute or chronic medical illness
- Current or recent gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Prior exposure to saxagliptin or dapagliflozin or related drugs
Data sourced from ClinicalTrials.gov (NCT01662999). 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. Informational only — not medical advice.