Phase 1
N=54
Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
Type2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02956044 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Cmax (Maximum Observed Plasma Concentration) — 124.6; 135.5; 158.6; 143.7 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Bexagliflozin (Drug); Metformin (Drug); Glimepiride (Drug); Sitagliptin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theracos
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximum Observed Plasma Concentration) |
124.6; 135.5; 158.6; 143.7; 117.1; 148.3 | — |
| PRIMARY Tmax (Time of Maximum Observed Plasma Concentration) |
4.0; 3.0; 8.0; 6.0; 3.0; 4.0 | — |
| PRIMARY T1/2 (Apparent Terminal Elimination Half-life) |
10.3; 7.8; 8.0; 7.8; 12.6; 13.3 | — |
| PRIMARY AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) |
1154.4; 1008.6; 1204.9; 1162.2; 1011.8; 1158.1 | — |
| SECONDARY Urinary Glucose Excretion up to 0-72 hr |
31.57; 0.02; 26.26; 36.99; 1.26; 31.02 | — |
Summary
The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin, glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.
Eligibility Criteria
Inclusion Criteria
- Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- Subjects who are non-smokers for at least 3 months prior to screening
- Subjects who are willing and able to be confined to the clinical research facility as required by the protocol
Exclusion Criteria
- Subjects with a clinically significant history of allergy to drugs or latex.
- Subjects with a history of alcohol or drug dependence in the past 12 months.
- Subjects who have donated a significant amount of blood in the past 2 months
- Female subjects who are pregnant or breastfeeding
- Subjects who are not willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic
- Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
- Subjects who had previously received anti-diabetic medication, including metformin, sitagliptin, glimepiride or drugs of the same class (i.e. biguanides, DPP-4 inhibitors or sulfonylureas), or SGLT2 inhibitors, in the past 3 months
Data sourced from ClinicalTrials.gov (NCT02956044). 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.