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Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

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ClinicalTrials.gov Identifier: NCT02956044
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Brief 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Drug: Bexagliflozin Drug: Metformin Drug: Glimepiride Drug: Sitagliptin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Randomized, Three-period, Crossover Study to Evaluate Pharmacokinetic Interaction Between Bexagliflozin Tablets and Metformin, Glimepiride, or Sitagliptin in Healthy Subjects
Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Active Comparator: Group 1: Bexagliflozin alone Drug: Bexagliflozin
Bexagliflozin tablets, 20 mg

Active Comparator: Group 1: Metformin alone Drug: Metformin
1000 mg metformin

Active Comparator: Group 1: Bexagliflozin + Metformin Drug: Bexagliflozin
Bexagliflozin tablets, 20 mg

Drug: Metformin
1000 mg metformin

Active Comparator: Group 2: Bexagliflozin alone Drug: Bexagliflozin
Bexagliflozin tablets, 20 mg

Active Comparator: Group 2: Glimepiride alone Drug: Glimepiride
4 mg glimepiride

Active Comparator: Group 2: Bexagliflozin + Glimepiride Drug: Bexagliflozin
Bexagliflozin tablets, 20 mg

Drug: Glimepiride
4 mg glimepiride

Active Comparator: Group 3: Bexagliflozin alone Drug: Bexagliflozin
Bexagliflozin tablets, 20 mg

Active Comparator: Group 3: Sitagliptin alone Drug: Sitagliptin
100 mg sitagliptin

Active Comparator: Group 3: Bexagliflozin + Sitagliptin Drug: Bexagliflozin
Bexagliflozin tablets, 20 mg

Drug: Sitagliptin
100 mg sitagliptin




Primary Outcome Measures :
  1. Cmax (Maximum observed plasma concentration) [ Time Frame: Up to 72 hours ]
  2. Tmax (Time of maximum observed plasma concentration) [ Time Frame: Up to 72 hours ]
  3. T1/2 (Apparent terminal elimination half-life) [ Time Frame: Up to 72 hours ]
  4. AUC0-inf (Area under the plasma concentration-time curve from Time 0 to infinity) [ Time Frame: Up to 72 hours ]

Secondary Outcome Measures :
  1. Urinary Glucose Excretion 0-12 hr [ Time Frame: 0-12 hr ]
  2. Urinary Glucose Excretion 12-24 hr [ Time Frame: 12-24 hr ]
  3. Urinary Glucose Excretion 24-36 hr [ Time Frame: 24-36 hr ]
  4. Urinary Glucose Excretion 36-48 hr [ Time Frame: 36-48 hr ]
  5. Safety as measured by adverse events [ Time Frame: up to 2 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
  2. Subjects who are non-smokers for at least 3 months prior to screening
  3. Subjects who are willing and able to be confined to the clinical research facility as required by the protocol

Exclusion Criteria:

  1. Subjects with a clinically significant history of allergy to drugs or latex.
  2. Subjects with a history of alcohol or drug dependence in the past 12 months.
  3. Subjects who have donated a significant amount of blood in the past 2 months
  4. Female subjects who are pregnant or breastfeeding
  5. Subjects who are not willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic
  6. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
  7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956044


Locations
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United States, Indiana
Clinical Research Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Theracos
Investigators
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Study Chair: Mason Freeman, M.D. Massachusetts General Hospital

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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT02956044     History of Changes
Other Study ID Numbers: THR-1442-C-453
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors