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NCT01311076 · ClinicalTrials.gov registry record · Phase 1

TAK-329 Glucose Clamp Study

A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
37
Enrollment target
1
Study location

NCT01311076: Completed Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Takeda.

NCT01311076 is a Phase 1 study of Type 1 Diabetes Mellitus that has completed, run by Takeda. The registered enrollment target is 37 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01311076, a Phase 1 study of Type 1 Diabetes Mellitus, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the safety, tolerability, pharmacokinetic and pharmacodynamic properties of single doses of TAK-329 with a single dose of a subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes mellitus.

Primary Outcome

(AUCGIR 0-360) is measure of area under the curve of the glucose infusion rate from time 0 to 360 minutes (6 hours) post dose, measured in minutes during the glucose clamp procedure.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Insulin
  • DRUG TAK-329

Study Locations (1)

California

  • - Chula Vista

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2011-03
Est. Completion 2012-01
Phase Phase 1
Takeda

408 total trials

What the finished NCT01311076 record still lists

NCT01311076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (78% lower).

The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01311076 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01311076 about?

NCT01311076 is a clinical study titled "TAK-329 Glucose Clamp Study". The purpose of this study is to compare the safety, tolerability, pharmacokinetic and pharmacodynamic properties of single doses of TAK-329 with a single dose of a subcutaneously-injected rapid-acting insulin analog in participants with type 1 diabetes mellitus.

What is the current status of trial NCT01311076?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2011-03. Estimated completion is 2012-01.

What conditions does trial NCT01311076 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.

What interventions are being tested in trial NCT01311076?

The interventions under investigation include: Placebo (DRUG), Insulin (DRUG), TAK-329 (DRUG).

Who is sponsoring clinical trial NCT01311076?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01311076 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 1 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01311076's enrollment target sits among peer trials

37 61st of 112 higher than 50 of 112 other Type 1 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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 NCT01311076, the US trial registry maintained by the National Library of Medicine. NCT01311076 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.