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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

December 14, 2006
July 9, 2012
November 2006
March 2008   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c change from baseline after 26 weeks of treatment
Complete list of historical versions of study NCT00411892 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Fasting plasma glucose
  • lipid profiles
  • frequency of hypoglycaemic episodes after 26 weeks of treatment
  • glucose profiles
  • Change in body weight
Not Provided
Not Provided
 
Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: pioglitazone
    Tablets, 45 mg/day.
  • Drug: inhaled human insulin
    Treat-to-target dose titration scheme, inhalation.
    Other Name: NN1998
  • Experimental: A
    Interventions:
    • Drug: pioglitazone
    • Drug: inhaled human insulin
  • Active Comparator: B
    Intervention: Drug: pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
196
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00411892
NN1998-1683
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Theresa Brennan Novo Nordisk A/S
Novo Nordisk A/S
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP