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:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Theresa Brennan Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014