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Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00348712
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : July 6, 2006
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin 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 : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
Actual Study Start Date : October 30, 2006
Actual Primary Completion Date : March 5, 2008
Actual Study Completion Date : March 5, 2008

Resource links provided by the National Library of Medicine

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.
Active Comparator: B Drug: rosiglitazone
Tablets, 4 mg once or twice daily.
Drug: metformin
Tablets, 2000 mg/day.



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

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: For the duration of the trial ]
  2. Body weight [ Time Frame: For the duration of the trial ]
  3. Lung function [ Time Frame: For the duration of the trial ]
  4. Blood glucose [ Time Frame: For the duration of the trial ]
  5. Hypoglycaemia [ Time Frame: For the duration of the trial ]


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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
  • Treated with OAD(s) for more than or equal to 2 months
  • Body mass index of (BMI) less than or equal to 40.0 kg/m2
  • HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

  • Recurrent major hypoglycaemia
  • Current smoking or smoking within the last 6 months
  • Impaired hepatic or renal function
  • Cardiac disorders
  • Uncontrolled hypertension
  • Proliferative retinopathy or maculopathy

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): NCT00348712


  Show 74 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00348712     History of Changes
Other Study ID Numbers: NN1998-1390
2006-000796-15 ( EudraCT Number )
First Posted: July 6, 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
Rosiglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs