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

A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00330473

Enrollment

1019

Registered

2006-05-26

Start date

2006-06-30

Completion date

2008-05-31

Last updated

2019-09-16

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

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.

Interventions

DRUGHuman Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)

DRUGInsulin

patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To assess acceptance of insulin therapy	9 months
To assess blood sugar control as measured by HbA1c	baseline, 1,3,5,7,9 months

Secondary

Measure	Time frame
To assess patient-reported outcomes based on the W-BQ12 questionnaire	screening, baseline, months 5, and 9
To measure changes in HbA1c over time	baseline, 1,3,5,7,9 months
To assess patient-reported outcomes based on the DTSQ Questionnaire	Screening,baseline, months 5 and 9
To assess patient-reported outcomes based on the DSC-R questionnaire	screening,baseline, months 5 and 9
To assess safety by review of adverse events	throughout study

Countries

Argentina, Brazil, Canada, Denmark, India, Mexico, Poland, Puerto Rico, Russia, South Africa, South Korea, United States

Outcome results

None listed

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