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NCT01042106 · ClinicalTrials.gov registry record · Phase 1

Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults

A Phase 1 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT01042106: Completed Phase 1 study, sponsored by Sumitomo Pharma America.

NCT01042106 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01042106, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.

Interventions

  • DRUG Placebo
  • DRUG DSP-8658

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2009-11
Est. Completion 2010-07
Phase Phase 1
Sumitomo Pharma America

168 total trials

What the finished NCT01042106 record still lists

NCT01042106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01042106 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01042106 about?

NCT01042106 is a clinical study titled "Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.

What is the current status of trial NCT01042106?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2009-11. Estimated completion is 2010-07.

What interventions are being tested in trial NCT01042106?

The interventions under investigation include: Placebo (DRUG), DSP-8658 (DRUG).

Who is sponsoring clinical trial NCT01042106?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01042106's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01042106, the US trial registry maintained by the National Library of Medicine. NCT01042106 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.