Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

MannKind

Status and phase: Completed; Phase 3

Conditions: Diabetes, Type 2; Diabetes, Type 1

Treatments: Drug: Technosphere® Insulin Inhalation Powder; Drug: Usual Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308737

MKC-TI-030

Details and patient eligibility

About

Pulmonary Safety in Diabetics with T/I

Enrollment: 2,053 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• For All Subjects:

  • Nonsmoking
  • Body mass index <42 kg/m2
  • FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
  • No abnormalities in screening pulmonary radiology

• For Subjects with diabetes mellitus:

  • Type 1 or type 2 diabetes for at least 2 years
  • HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %

• For Subjects without abnormalities in glucose control:

  • No history of diabetes
  • Normal results from a formal glucose tolerance test

Exclusion criteria

• History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
• Significant renal, hepatic, or cardiac disease
• Women who are pregnant, lactating, or planning on becoming pregnant
• Subjects who have participated in studies of other investigational drugs within the previous 3 months
• Evidence of severe complications of diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,053 participants in 3 patient groups

TI Inhalation Powder

Experimental group

Description:

Technosphere® Insulin Inhalation Powder

Treatment:

Drug: Technosphere® Insulin Inhalation Powder

Usual care

Other group

Description:

Usual care

Treatment:

Drug: Usual Care

Non-diabetes

No Intervention group

Description:

Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)