A Study for Patients With Type 2 Diabetes Mellitus

A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00490854

Enrollment

129

Registered

2007-06-25

Start date

2007-07-31

Completion date

2008-05-31

Last updated

2008-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.

Interventions

DRUGHuman Insulin Inhalation Powder

patient specific, inhaled, at meals, 76 weeks

DRUGNeutral protamine hagedorn insulin

patient specific dose, injected, daily, 76 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Type 2 diabetes mellitus for at least 6 months 2. One or more oral antihyperglycemic medications for at least 12 weeks 3. HbA1c equal to or greater than 7.0%, and equal to or less than 10.5% 4. Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study 5. Satisfactory lung function results to meet the requirement of the study

Exclusion criteria

1. Previously received any form of inhaled insulin 2. Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease 3. History or presence of liver disease 4. History or presence of kidney disease

Design outcomes

Primary

Measure	Time frame
Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase	24, 48 and 76 weeks after Randomization

Secondary

Measure	Time frame
8-point SMBG profiles.	24, 48 and 76 weeks after Randomization
Mean change in HbA1c from baseline to the end.	24, 48 and 76 weeks after Randomization
Mean dosage of both preprandial and basal insulin.	24, 48 and 76 weeks after Randomization
Inhaler reliability.	24, 48 and 76 weeks after Randomization
Patient-reported outcomes questionnaires.	24, 48 and 76 weeks after Randomization

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026