Type 2 Diabetes MellitusPhase 1NCT01525238

PK Study of Dapagliflozin in Pediatric Subjects With T2DM

A Phase 1 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 17 sites in 2 countries.

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 primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM) Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 17 sitesin 2 countries
Study dates: 1 Jul 2012to 1 Sep 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Clinical diagnosis of T2DM
Male and female subjects ages 10-17
Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
Body weight ≥30 kg

Who cannot join

Fasting plasma glucose (FPG) >240 mg/dL at screening
Abnormal renal function
Active liver disease and/or significant abnormal liver function

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States14 sites

Emory University
Atlanta, Georgia, 30322
The Children Hospital Of Alabama
Birmingham, Alabama, 35233
Women And Children'S Hopsital Of Buffalo
Buffalo, New York, 14222
Childrens Mercy Hospital
Kansas City, Missouri, 64108
Axis Clinical Trials
Los Angeles, California, 90036
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
Methodist Le Bonheur Hlthcare
Memphis, Tennessee, 38103
Nemours Childrens Hospital
Orlando, Florida, 32827
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Children'S Hospital Of Pittsburgh Of Upmc
Pittsburgh, Pennsylvania, 15224
Christus Santa Rosa Childrens Hospital
San Antonio, Texas, 78207
Lsuhsc-Shreveport
Shreveport, Louisiana, 71103
Promedica Toledo Children'S Hospital
Toledo, Ohio, 43606
Mercy Children'S Hospital
Toledo, Ohio, 43608

Other trials in United States

Mexico3 sites

Local Institution
Guadalajara, Jalisco, 44150
Local Institution
Monterrey, Nuevo León, 64460
Local Institution
Veracruz, 91910

Other trials in Mexico

About this study

Official title: A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Read the detailed description

Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin
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.

DapagliflozinDrug
Tablet, Oral, 2.5 mg, Single-dose
DapagliflozinDrug
Tablet, Oral, 5 mg, Single-dose
DapagliflozinDrug
Tablet, Oral, 10 mg, Single-dose

Study groups in NCT01525238
Study group	Role	What they receive
Dapagliflozin 2.5 mg	Experimental	Not described Receives: Drug: Dapagliflozin
Dapagliflozin 5 mg	Experimental	Not described Receives: Drug: Dapagliflozin
Dapagliflozin 10 mg	Experimental	Not described Receives: Drug: Dapagliflozin

What is being measured

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

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin
Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin
Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Mean Plasma Half-life (T-HALF) of Dapagliflozin
Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin
Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin
Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Secondary outcomes (13)

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide
Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide
Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide
Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours.
Measured: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting
Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL).
Measured: Day 1 (Pre-dose) to Day 2
Mean Change in Fasting Plasma Glucose From Baseline Until Day 2
Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL).
Measured: Day 1 (Pre-dose) to Day 2
Mean Total Amount of Glucose Excreted in Urine Over 24 Hours
The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams.
Measured: Time of dose to 24 hours post-dose, Day 1 to Day 2
Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.
Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported.
Measured: Day 1 to Day 3
Number of Participants With Marked Hematology Laboratory Abnormalities
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (x10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx). Leukocytes (x10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre- Rx>ULN, use >1.15*Pre-Rx or <LLN). Neutrophils (Absolute) (x10^3 c/uL): <=1.5. Lymphocytes (Absolute) (x10^3 c/uL): <0.75 or >7.5. Monocytes (Absolute) (x10^3 c/uL): >2.000. Basophils (x10^3 c/uL): >0.4. Eosinophils (Absolute) (x10^3 c/uL): >0.75. Blasts (Absolute) (x10^9 c/L) > 0.
Measured: Day 1 (Pre-dose) to Day 3
Number of Participants With Marked Serum Chemistry Abnormalities
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): >1.5*ULN if Pre-Rx missing or <= ULN, >1.33*Pre-Rx if PreRx > ULN. Sodium (mmol/L): >1.05*ULN, 1.05*Pre-Rx if Pre-Rx>ULN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN). Potassium(mmol/L), Chloride (mmol/L), Calcium(mmol/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN).
Measured: Day 1 (Pre-dose) to Day 3
Number of Participants With Marked Abnormalities in Other Chemistry Testing
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose, fasting serum (mmol/L): <0.8*LLN, >1.3*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN). Protein (grams per deciliter: g/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Albumin (g/L): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mmol/L): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)
Measured: Day 1 (Pre-dose) to Day 3
Number of Participants With Marked Urinalysis Abnormalities
LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Blood, urine (Qualitative): >=2 (If Pre-Rx >= 1, >=2*Pre-Rx). Glucose, urine (Qualitative): >=1, (If Pre-Rx >=1, >=2*Pre-Rx). Protein, urine (Qualitative): >=2 (If Pre-Rx >=1, >=2*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): >=2 (If Pre-Rx>=2, >=4). White Blood Cells (WBC), urine (hpf): >=2 (If Pre-Rx>=2, >=4).
Measured: Day 1 (Pre-dose) to Day 3

Timeline

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

1 Jul 20121 Sep 2014

First posted2 Feb 2012 (estimated)
Study start1 Jul 2012
Primary completion1 Sep 2014
Study completion1 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525238
Sponsor's protocol ID: MB102-091
Other IDs: 2011-005225-40
Status last verified: Apr 2017
First submitted: 31 Jan 2012
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01525238
Acronym / sponsor ID: MB102-091
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: 1 Jul 2012 (actual)
Primary completion: 1 Sep 2014 (actual)
Study completion: 1 Sep 2014 (actual)
First posted: 2 Feb 2012 (estimated)
Results: Posted 21 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Detailed description

Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dapagliflozin 2.5 mg	Experimental	Drug: Dapagliflozin
Dapagliflozin 5 mg	Experimental	Drug: Dapagliflozin
Dapagliflozin 10 mg	Experimental	Drug: Dapagliflozin

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Clinical diagnosis of T2DM
Male and female subjects ages 10-17
Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
Body weight ≥30 kg

Key exclusion criteria (3 listed)

Fasting plasma glucose (FPG) >240 mg/dL at screening
Abnormal renal function
Active liver disease and/or significant abnormal liver function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinTablet, Oral, 2.5 mg, Single-dose	Drug	Dapagliflozin 2.5 mg
DapagliflozinTablet, Oral, 5 mg, Single-dose	Drug	Dapagliflozin 5 mg
DapagliflozinTablet, Oral, 10 mg, Single-dose	Drug	Dapagliflozin 10 mg

Primary outcome

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).
Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Mean Plasma Half-life (T-HALF) of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.
Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).
Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)

13 secondary outcomes

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide
Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting
Time frame: Day 1 (Pre-dose) to Day 2
Mean Change in Fasting Plasma Glucose From Baseline Until Day 2
Time frame: Day 1 (Pre-dose) to Day 2
Mean Total Amount of Glucose Excreted in Urine Over 24 Hours
Time frame: Time of dose to 24 hours post-dose, Day 1 to Day 2
Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.
Time frame: Day 1 to Day 3
Number of Participants With Marked Hematology Laboratory Abnormalities
Time frame: Day 1 (Pre-dose) to Day 3
Number of Participants With Marked Serum Chemistry Abnormalities
Time frame: Day 1 (Pre-dose) to Day 3
Number of Participants With Marked Abnormalities in Other Chemistry Testing
Time frame: Day 1 (Pre-dose) to Day 3
Number of Participants With Marked Urinalysis Abnormalities
Time frame: Day 1 (Pre-dose) to Day 3

Results and safety

Results posted to the registry on 21 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin 2.5 mg	8	7
Dapagliflozin 5 mg	8	8
Dapagliflozin 10 mg	8	8

Primary outcome: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin

Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Dapagliflozin 2.5 mg n = 7	Dapagliflozin 5 mg n = 8	Dapagliflozin 10 mg n = 8
Value	24.8 (34)	48.4 (41)	118 (35)

Population analysed: All treated participants with evaluable pharmacokinetic (PK) profiles

Primary outcome: Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin

Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose. Median (Full Range). Unit: hours

Measure	Dapagliflozin 2.5 mg n = 7	Dapagliflozin 5 mg n = 8	Dapagliflozin 10 mg n = 8
Value	1.50 (0.75 to 2.00)	0.960 (0.58 to 1.53)	0.875 (0.75 to 4.00)

Population analysed: All treated participants with evaluable PK profiles.

Primary outcome: Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin

Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Dapagliflozin 2.5 mg n = 7	Dapagliflozin 5 mg n = 8	Dapagliflozin 10 mg n = 8
Value	101 (23)	199 (29)	427 (31)

Population analysed: All treated participants with evaluable PK profiles

Primary outcome: Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin

Time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Dapagliflozin 2.5 mg n = 7	Dapagliflozin 5 mg n = 8	Dapagliflozin 10 mg n = 8
Value	92.3 (27)	189 (31)	418 (31)

Population analysed: All treated participants with evaluable PK profiles

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs collected from Screening (up to 28 days before first dose) to 30 days after last dose; Non-serious AEs collected from time of dose (Day 1) to Study Discharge (Day 3) and followed until resolution, stabilization, or reclassification as SAE.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 2.5 mg	0 of 8 (0%)	2 of 8 (25%)	Not reported
Dapagliflozin 5 mg	0 of 8 (0%)	0 of 8 (0%)	Not reported
Dapagliflozin 10 mg	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 17 sites in 2 countries.

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 3 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin (time frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose). The study lists 7 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 NCT01525238.

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 30 May 2017.