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NCT00850096 · ClinicalTrials.gov registry record · Phase 2

Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus

A Phase 2 study of Type 2 Diabetes, sponsored by CPEX Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
94
Enrollment target
20
Study locations

NCT00850096: Completed Phase 2 study of Type 2 Diabetes, sponsored by CPEX Pharmaceuticals.

NCT00850096 is a Phase 2 study of Type 2 Diabetes that has completed, run by CPEX Pharmaceuticals. The registered enrollment target is 94 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00850096, a Phase 2 study of Type 2 Diabetes, has completed, sponsored by CPEX Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
94 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is: * To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes. * To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes

Primary Outcome

Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.

Conditions Studied

Interventions

  • OTHER Placebo for Nasulin
  • DRUG Nasulin

Study Locations (20)

California

  • AMCR Institute, Inc - Escondido
  • Scripps Whittier Diabetes Clinic - La Jolla
  • Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst. - San Mateo
  • Diablo Clinical Research - Walnut Creek

Florida

  • Clinical Research of West Florida - Clearwater
  • University of Miami Diabetes Research Institute - Miami
  • Metabolic Research Institute - West Palm Beach

North Carolina

  • Mountain Diabetes and Endocrine Center - Asheville
  • ECU Diabetes Research Center - Greenville
  • Physician's East PA - Greenville

Texas

  • Texas Diabetes and Endocrinology - Austin
  • University of Texas; Southwestern Medical Center - Dallas

Arizona

  • Radiant Research - Chandler

Colorado

  • Barbara Davis Center - Aurora

Georgia

  • Atlanta Diabetes Associates - Atlanta

Hawaii

  • East-West Medical Research Institute - Honolulu

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2009-01
Est. Completion 2010-03
Phase Phase 2
CPEX Pharmaceuticals

1 total trials

What the finished NCT00850096 record still lists

NCT00850096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (98% lower).

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

NCT00850096 names 20 study sites across 12 states, led by California, Florida, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00850096 about?

NCT00850096 is a clinical study titled "Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus". The purpose of this study is: * To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes. * To asses the safety and tolerability of Nauslin at 50 IU...

What is the current status of trial NCT00850096?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2009-01. Estimated completion is 2010-03.

What conditions does trial NCT00850096 study?

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

What interventions are being tested in trial NCT00850096?

The interventions under investigation include: Placebo for Nasulin (OTHER), Nasulin (DRUG).

Who is sponsoring clinical trial NCT00850096?

This trial is sponsored by CPEX Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00850096 being conducted?

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

Similar trials for Type 2 Diabetes

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 NCT00850096's enrollment target sits among peer trials

94 165th of 327 higher than 163 of 327 other Type 2 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes 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 NCT00850096, the US trial registry maintained by the National Library of Medicine. NCT00850096 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.