NCT00427154|TerminatedPhase 3

Study Stopped

See termination reason in detailed description

Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN1998-1540

Study Type

interventional

Target

227

Locations

1 country

Sites

103

Timeline

RegisteredJan 2007

StartedJan 2007

CompletionMar 2008

Brief Summary

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in combination with metformin and glimepiride.

Trial Health

Monitor

Trial Health Score

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

Enrollment

227

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jan 2007

Geographic Reach

1 country

103 active sites

Status

terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

January 10, 2007

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2008

Completed

Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

January 25, 2007

Last Update Submit

September 3, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
After 26 weeks

Secondary Outcomes (5)

Fasting plasma glucose
For the duration of the trial
Lipid profiles
For the duration of the trial
Hypoglycaemic episodes
For the duration of the trial
Glucose profiles
For the duration of the trial
Change in body weight
For the duration of the trial

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: inhaled human insulinDrug: metforminDrug: glimepiride

B

ACTIVE COMPARATOR

Drug: rosiglitazoneDrug: metforminDrug: glimepiride

Interventions

rosiglitazoneDRUG

Tablets, 4 mg once or twice daily.

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

Also known as: NN1998

metforminDRUG

Tablets, 2000 mg/day.

glimepirideDRUG

Tablets, 8 mg/day.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
BMI less than or equal to 40 kg/m2

You may not qualify if:

Current smoking or smoking within the last 6 months
Current acute or chronic pulmonary disease (except for asthma)
Proliferative retinopathy requiring acute treatment
Clinically significant disease history including kidney or liver disease
Heart disease which limits physical activity or results in discomfort with physical activity
Pregnancy

Contact the study team to confirm eligibility.