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Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00427154
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : January 26, 2007
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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 or rosiglitazone treatment, both in combination with metformin and glimepiride.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin Drug: glimepiride 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes
Actual Study Start Date : January 10, 2007
Primary Completion Date : March 11, 2008
Study Completion Date : March 11, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Name: NN1998
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 8 mg/day.
Active Comparator: B Drug: rosiglitazone
Tablets, 4 mg once or twice daily.
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 8 mg/day.

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: After 26 weeks ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: For the duration of the trial ]
  2. Lipid profiles [ Time Frame: For the duration of the trial ]
  3. Hypoglycaemic episodes [ Time Frame: For the duration of the trial ]
  4. Glucose profiles [ Time Frame: For the duration of the trial ]
  5. Change in body weight [ Time Frame: For the duration of the trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
  • HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
  • BMI less than or equal to 40 kg/m2

Exclusion Criteria:

  • Current smoking or smoking within the last 6 months
  • Current acute or chronic pulmonary disease (except for asthma)
  • Proliferative retinopathy requiring acute treatment
  • Clinically significant disease history including kidney or liver disease
  • Heart disease which limits physical activity or results in discomfort with physical activity
  • Pregnancy

Information from the National Library of Medicine

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): NCT00427154

  Show 103 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00427154     History of Changes
Other Study ID Numbers: NN1998-1540
First Posted: January 26, 2007    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
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors