Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.
Interventions
DRUGLY041001 (HIIP)
Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
Sponsors
Alkermes, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes for at least 12 months * Age 18 or older. * Taking at least 1 oral antihyperglycemic medication. * Have an HbA1C between 7.5 and 12. * Be a nonsmoker
Exclusion criteria
* Body Mass Index (BMI) greater than 40. * Have frequent episodes of severe hypoglycemia. * Have advanced autonomic neuropathy. * Have history of asthma. * Have chronic obstructive pulmonary disease (COPD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess the suitability of the HIIP delivery system for type 2 diabetes patients | 4 weeks |
| Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training | 4 weeks |
| Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training | 4 weeks |
Countries
Argentina, Portugal, South Africa, United States
Outcome results
None listed