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NCT01451398 · ClinicalTrials.gov registry record · Phase 3

Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

A Phase 3 study of Type 2 Diabetes, sponsored by Mannkind Corporation.

Completed
Registry status
Phase 3
Development phase
353
Enrollment target
20
Study locations

NCT01451398 is a Phase 3 study of Type 2 Diabetes that has completed, run by Mannkind Corporation. The registered enrollment target is 353 participants, below the 1,101-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT01451398, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by Mannkind Corporation.

COMPLETED
Registry status
Phase 3
Development phase
353 participants
Enrollment target
20
Study locations

Study Summary

Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

Conditions Studied

Interventions

  • DRUG Technosphere® Insulin
  • DRUG Technosphere Powder

Study Locations (20)

Florida

  • - Hialeah
  • - Hollywood
  • - Miami
  • - Miami
  • - New Port Richey
  • - North Miami Beach
  • - Pembroke Pines
  • - Pinellas Park
  • - West Palm Beach

California

  • - Anaheim
  • - Huntington Beach
  • - Laguna Hills
  • - Long Beach
  • - Los Angeles
  • - Los Gatos
  • - Tustin
  • - West Hills

Georgia

  • - Atlanta
  • - Atlanta
  • - Dunwoody

Trial Details

FieldValue
Enrollment Target 353 participants
Start Date 2011-11
Est. Completion 2013-07
Phase Phase 3

Sponsor

Mannkind Corporation

42 total trials

What the Registry Record Tells You About NCT01451398

The ClinicalTrials.gov registry entry for NCT01451398 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,101-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (68% lower). The listed sponsor is Mannkind Corporation, which has 42 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Technosphere® Insulin is the first listed.

NCT01451398 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01451398 about?

NCT01451398 is a clinical study titled "Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus". Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (plac...

What is the current status of trial NCT01451398?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2011-11. Estimated completion is 2013-07.

What conditions does trial NCT01451398 study?

This clinical trial studies the following conditions: Type 2 Diabetes.

What interventions are being tested in trial NCT01451398?

The interventions under investigation include: Technosphere® Insulin (DRUG), Technosphere Powder (DRUG).

Who is sponsoring clinical trial NCT01451398?

This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01451398 being conducted?

This trial has 20 study locations across California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.