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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
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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 and pioglitazone combination therapy versus pioglitazone treatment alone.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: pioglitazone Drug: inhaled human insulin Phase 3

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.

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ]
  2. Lipid profiles [ Time Frame: after 26 weeks of treatment ]
  3. Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ]
  4. Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ]
  5. Change in body weight [ Time Frame: after 26 weeks of treatment ]

Eligibility Criteria
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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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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