A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin; Drug: Human Insulin Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00330473

H7U-MC-IDAW (Other Identifier)

9628

Details and patient eligibility

About

A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.

Enrollment: 1,019 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes
• Insulin-naive
• Non-smoker

Exclusion criteria

• Significant pulmonary, hepatic or renal disease
• severe congestive heart failure
• active malignancy or malignancy within the last 5 years
• systemic glucocorticoid therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,019 participants in 2 patient groups

1

Experimental group

Description:

Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.

Treatment:

Drug: Human Insulin Inhalation Powder

2

Active Comparator group

Description:

Treatment Options available on the market.

Treatment:

Drug: Insulin