NCT00539396

Brief Summary

A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

First QC Date

October 3, 2007

Last Update Submit

October 12, 2009

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Change in blood glucose following a standard meal

    0-300 minutes

Secondary Outcomes (1)

  • Mean change from baseline HbA1c

    week 12

Interventions

Technosphere InsulinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
  • BMI \<40 kg/m squared
  • HbA1c greater than or equal to 7% and less than or equal to 11.5%
  • Serum creatinine less than 2 for males and less than 1.8 for females
  • Acceptable pulmonary function

You may not qualify if:

  • Significant hepatic disease
  • Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Robert Baughman, PhD

    Mannkind Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

March 1, 2005

Study Completion

December 1, 2005

Last Updated

October 14, 2009

Record last verified: 2009-10