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CompletedNCT01023945Updated Nov 12, 2024

A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

A Phase 1 interventional study of ASP1941 and Placebo in Type 2 Diabetes Mellitus, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • ASP1941
  • Diabetes mellitus
  • Blood glucose
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 30 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

Browse Astellas Pharma Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 diabetic patients for at least 12 weeks
  • HbA1c value between 7.0 and 10.0% at screening
  • Fasting plasma glucose ≥ 126mg/dL and \< 240mg/dL at screening
  • Body Mass Index (BMI) 20.0 - 45.0 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes mellitus patients
  • Serum creatinine > upper limit of normal
  • Proteinuria（albumin/creatinine ratio > 300mg/g）
  • Dysuria and/or urinary tract infection
  • Significant renal, hepatic or cardiovascular diseases
  • Severe gastrointestinal diseases
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    ASP1941 high dose group

    oral

    Drug: ASP1941

  • Experimental
    ASP1941 low dose group

    oral

    Drug: ASP1941

  • Placebo comparator
    Placebo group

    oral

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Change in plasma glucose levels

    Time frame: On day 14

Secondary outcomes

  1. Urinary glucose excursion

    Time frame: On day 14

  2. Pharmacokinetic parameter of ASP1941

    Time frame: On day 14

  3. Safety by adverse events, routine safety laboratories and vital signs.

    Time frame: During treatment

  4. Change in serum insulin levels

    Time frame: On day 14

07

Study locations

1 site
  • Kantou, Japan
08

References and documents

Publications

  • Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21. PubMed 32839028 ↗

Individual participant data

Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2009 to primary completion in Mar 2010, 4 months.

Of 393 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 4 months is below that.

Counting every sponsor, half of 458 studies reached it within 7 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2009
First posted
Dec 2, 2009
StartActual
Nov 7, 2009
Primary completionActual
Mar 26, 2010
CompletionActual
Mar 26, 2010
Last update
Nov 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01023945
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Dec 2, 2009
Start date
Nov 7, 2009
Primary completion
Mar 26, 2010
Completion
Mar 26, 2010
Last update
Nov 12, 2024

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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