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Type 2 Diabetes MellitusPhase 1NCT02060201

Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

A Phase 1 study testing Saxagliptin, Dapagliflozin and Saxagliptin/Dapagliflozin FDC in people with Type 2 Diabetes Mellitus, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Saxagliptin, Dapagliflozin and Saxagliptin/Dapagliflozin FDC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
No sites listed yet
Study dates
Feb 2014to May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (PE), vital signs, 12-lead ECG, and clinical laboratory determinations
  • Body mass index (BMI) of 18.5 to 30 kg/m(2)
  • Men and women, ages 18 to 50 years
  • Women of childbearing potential must use acceptable methods of highly effective birth control

Who cannot join

  • Any significant acute or chronic medical illness
  • Current or recent gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • History of chronic or recurrent urinary tract infection for females
  • History of glucose intolerance or diabetes mellitus
  • History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose cotransporter (SGLT) inhibitors
  • Prior exposure to Saxagliptin or Dapagliflozin or related drugs

About this study

Official title: A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

Read the detailed description

Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and Dapagliflozin tablets administered orally together in the fasted and fed state

Being tested
Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaxagliptinDrug

    Also called Onglyza®, BMS-477118

  • DapagliflozinDrug

    Also called Farxiga®, Forxiga®, BMS-512148

  • Saxagliptin/Dapagliflozin FDCDrug

    Also called BMS-986098

Study groups in NCT02060201
Study groupRoleWhat they receive
Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; FastingOtherSaxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods
Receives: Drug: Saxagliptin; Drug: Dapagliflozin
Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; FastingOtherSaxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Receives: Drug: Saxagliptin/Dapagliflozin FDC
Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; FedOtherSaxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Receives: Drug: Saxagliptin/Dapagliflozin FDC
Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; FastingOtherSaxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods
Receives: Drug: Saxagliptin; Drug: Dapagliflozin
Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; FastingOtherSaxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Receives: Drug: Saxagliptin/Dapagliflozin FDC
Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; FedOtherSaxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Receives: Drug: Saxagliptin/Dapagliflozin FDC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  2. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  3. Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days

Secondary outcomes (10)

  1. Cmax for 5-hydroxy (OH) Saxagliptin

    Measured: 54 time points up to 15 days

  2. AUC(0-T) for 5-hydroxy (OH) Saxagliptin

    Measured: 54 time points up to 15 days

  3. AUC(INF) for 5-hydroxy (OH) Saxagliptin

    Measured: 54 time points up to 15 days

  4. Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  5. Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  6. Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  7. Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  8. Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  9. Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin

    Measured: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days

  10. Safety measured by the occurrence of deaths, adverse events (AEs), serious adverse events (SAEs), results of clinical laboratory tests, vital sign measurements, physical examination findings, and 12-lead electrocardiogram (ECG) results

    Measured: Approximately up to 16 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02060201
Sponsor's protocol ID
CV181-341
Other IDs
118,840
Status last verified
Jun 2015
First submitted
10 Feb 2014
Last updated
10 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Saxagliptin, Dapagliflozin and Saxagliptin/Dapagliflozin FDC in people with Type 2 Diabetes Mellitus, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin (time frame: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.

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