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: February 28, 2017
Last verified: February 2017
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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 Intervention Model: Parallel Assignment Masking: No masking 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 196 |
| Actual Study Start Date: | November 29, 2006 |
| Study Completion Date: | March 18, 2008 |
| Primary Completion Date: | March 18, 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) |
| Sexes Eligible for Study: | All |
| 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 110 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411892
Show 110 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | 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: | February 28, 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 |
ClinicalTrials.gov processed this record on May 23, 2017