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OpenTrials
Completed

NCT Number: NCT00539396

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

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Technosphere Insulin

Drug

Primary outcomes

  1. Change in blood glucose following a standard meal

    Time frame: 0-300 minutes

Secondary outcomes

  1. Mean change from baseline HbA1c

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study title

A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus

Important dates

Study start
2005
Study completion
2005
First posted
Oct 4, 2007
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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