Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00411892
First received: December 14, 2006
Last updated: July 9, 2012
Last verified: July 2012
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Purpose
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 and pioglitazone combination therapy versus pioglitazone treatment alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: pioglitazone Drug: inhaled human insulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Lipid profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ] [ Designated as safety issue: No ]
- Change in body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 196 |
| Study Start Date: | November 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411892
Show 87 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411892
Show 87 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Theresa Brennan | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00411892 History of Changes |
| Other Study ID Numbers: | NN1998-1683 |
| Study First Received: | December 14, 2006 |
| Last Updated: | July 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 28, 2016