CClinicalTrials.gg
CompletedNCT00790660Updated Nov 14, 2024

A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

A Phase 2 interventional study of ASP1941 and Placebo in Diabetes Mellitus, Type 2, sponsored by Astellas Pharma Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Read the detailed description

Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • ASP1941
  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 61 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Established diagnosis of type 2 diabetes mellitus
  • HbA1c value between 7.0 and 10.0%
  • Body mass index between 20 and 45 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Established diagnosis of type 1 diabetes mellitus
  • Serum creatinine > upper limit of normal range
  • Proteinuria (microalbumin/creatinine ratio > 300 mg/g)
  • Urinary tract infection
  • Severe uncontrolled Hypertension
  • Significant renal, hepatic or cardiovascular disease
  • HIV Positive
  • History of drug or alcohol abuse/dependency
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    ASP1941 Lowest Dose

    Oral

    Drug: ASP1941

  • Experimental
    ASP1941 Low Dose

    Oral

    Drug: ASP1941

  • Experimental
    ASP1941 Medium Dose

    Oral

    Drug: ASP1941

  • Experimental
    ASP1941 High Dose

    Oral

    Drug: ASP1941

  • Placebo comparator
    Placebo

    Oral

    Drug: Placebo

Interventions

  • DrugASP1941

    Oral

  • DrugPlacebo

    Oral

06

What researchers measure

Primary outcomes

  1. Evaluation of safety through clinical safety labs and adverse events

    Time frame: 6 Weeks

Secondary outcomes

  1. Evaluation of routine PK and PD parameters

    Time frame: 6 Weeks

07

Study locations

1 site
  • San Antonio, Texas 78229, United States
08

References and documents

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00790660
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Nov 13, 2008
Start date
Oct 23, 2008
Primary completion
Mar 6, 2009
Completion
Mar 6, 2009
Last update
Nov 14, 2024

Study contacts

use Central Contact
study director · Astellas Pharma Global Development

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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