Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00411892 |
Recruitment Status
:
Terminated
(See termination reason in detailed description)
First Posted
: December 15, 2006
Last Update Posted
: March 1, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: pioglitazone Drug: inhaled human insulin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 196 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes |
Actual Study Start Date : | November 29, 2006 |
Actual Primary Completion Date : | March 18, 2008 |
Actual Study Completion Date : | March 18, 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: pioglitazone
Tablets, 45 mg/day.
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Name: NN1998
|
Active Comparator: B |
Drug: pioglitazone
Tablets, 45 mg/day.
|
- HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ]
- Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ]
- Lipid profiles [ Time Frame: after 26 weeks of treatment ]
- Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ]
- Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ]
- Change in body weight [ Time Frame: after 26 weeks of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 diabetes
- Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
- HbA1c between 7.0-11.0% if on OAD monotherapy
- HbA1c between 7.0-10.0% if on OAD combination therapy
- BMI less than or equal to 40 kg/m2
Exclusion Criteria:
- Current regular smoking or regular smoking within the last 6 months
- Current acute or chronic pulmonary disease (except for asthma)
- Proliferative retinopathy requiring treatment
- Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411892

Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00411892 History of Changes |
Other Study ID Numbers: |
NN1998-1683 |
First Posted: | December 15, 2006 Key Record Dates |
Last Update Posted: | March 1, 2017 |
Last Verified: | February 2017 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin, Globin Zinc Pioglitazone Insulin Hypoglycemic Agents Physiological Effects of Drugs |