Brief Summary

This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

363

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Oct 2006

Typical duration for phase_3 diabetes

Geographic Reach

7 countries

26 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

June 22, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2006

Completed

4 months until next milestone

Study Start

First participant enrolled

October 10, 2006

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2008

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

June 22, 2006

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Treatment difference in HbA1c
After 26 weeks

Secondary Outcomes (5)

Adverse events
For the duration of the trial
Body weight
during treatment
Lung function
after 26 weeks of treatment
Blood glucose
after 26 weeks of treatment
Hypoglycaemia
from 12-26 weeks of treatment

Study Arms (2)

A

EXPERIMENTAL

Drug: inhaled human insulinDrug: glimepiride

B

ACTIVE COMPARATOR

Drug: rosiglitazoneDrug: glimepiride

Interventions

rosiglitazoneDRUG

Tablets, 4 mg once or twice a day.

inhaled human insulinDRUG

Treat-to-target dose titration scheme, pre-prandial, inhalation.

Also known as: NN1998

glimepirideDRUG

Tablets, 4 mg/day.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes
Treated with OAD(s) for more than or equal to 2 months
Body mass index (BMI) less than or equal to 40.0 kg/m2
HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy

You may not qualify if:

Recurrent major hypoglycaemia
Current smoking or smoking within the last 6 months
Impaired hepatic or renal function
Cardiac problems
Uncontrolled hypertension
Proliferative retinopathy or maculopathy

Contact the study team to confirm eligibility.