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Diabetes Mellitus, Type 2Phase 1NCT00554450

Renal Impairment in Type 2 Diabetic Subjects

A Phase 1 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 4 sites in United States.

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 the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
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
40 participants
Where
4 sitesUnited States
Study dates
Mar 2006to Oct 2008
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 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects in the following groups:
  • Group A: Healthy Subjects with Normal Renal Function (CLcr > 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr > 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr > 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr < 30 mL/min) (and not receiving dialysis)
  • Men and WOCBP, ages 18 to 79 years old
  • Standard Exclusion Criteria, plus:
  • History of diabetic ketoacidosis
  • HbA*1c > 10%
  • Serum albumin < 2.0 gm/dL
  • Potassium < 3.0 or > 6.0 mEq/L

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Elite Research Institute

    Miami, Florida, 33169

  • Prism Research

    Saint Paul, Minnesota, 55114

  • Dgd Research, Inc.

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment

The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function

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.

Study groups in NCT00554450
Study groupRoleWhat they receive
Arm 1Experimental50 mg single dose
Receives: Drug: Dapagliflozin
Arm 2Experimental20 mg up to 7 days
Receives: Drug: Dapagliflozin

What is being measured

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

  1. Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine

    Measured: on Days -1, 1, 4 and 10

  2. Blood samples for serum glucose and creatinine will be collected

    Measured: on Days -1, 1, 4 and 10 at selected timepoints

  3. Blood and urine PK samples

    Measured: on Days 1, 4, 10

  4. Iohexol PK blood & urine samples for GFR assessment

    Measured: on Day -12 to -5

Secondary outcomes (5)

  1. AEs, vital signs

    Measured: scr, Days -1, 1, 4-11, discharge

  2. physical exams

    Measured: scr, Days -12 to -5, -1, discharge

  3. ECGs

    Measured: scr, Days,-1, 4, 7, discharge

  4. clinical labs

    Measured: scr, Day -1, 1, 4, 6, 8, 10, discharge

  5. The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only)

    Measured: on Days -1, 1, 4 and 10

Timeline

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

  1. First posted7 Nov 2007 (estimated)
  2. Study startMar 2006
  3. Primary completionOct 2008
  4. Study completionOct 2008

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00554450
Sponsor's protocol ID
MB102-007
Status last verified
Oct 2016
First submitted
5 Nov 2007
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.

    PubMed 23210765

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 4 sites in United States.

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 8 inclusion and 0 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

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?

Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine (time frame: on Days -1, 1, 4 and 10). The study lists 4 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 NCT00554450, which also lists 1 linked publication.

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 17 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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