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Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants

NCT ID: NCT01662999

Last Updated: 2015-05-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)

Treatment A: Saxagliptin 5mg, Tablet, Oral; Single dose Treatment B: Dapagliflozin 10mg, Tablet, Oral; single dose Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; single dose

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin

Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)

Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose. Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin

Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin

Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin

Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, Once daily, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

Interventions

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Saxagliptin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

Other Intervention Names

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Onglyza® BMS-477118 BMS-512148

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Icon Clinical Pharmacology

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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Vakkalagadda B, Lubin S, Reynolds L, Liang D, Marion AS, LaCreta F, Boulton DW. Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study. Clin Ther. 2016 Aug;38(8):1890-9. doi: 10.1016/j.clinthera.2016.07.005. Epub 2016 Aug 2.

Reference Type DERIVED
PMID: 27491280 (View on PubMed)

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CV181-191

Identifier Type: -

Identifier Source: org_study_id

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