Effect of Inhaled Pre-prandial Human Insulin 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:
NCT00427154
First received: January 25, 2007
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 or rosiglitazone treatment, both in combination with metformin and glimepiride.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: rosiglitazone
Drug: inhaled human insulin
Drug: metformin
Drug: glimepiride
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 Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride 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:
  • Change in HbA1c [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Lipid profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 227
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  • 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
  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: NCT00427154

  Show 80 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Yizhen Xu, M.D., Ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00427154     History of Changes
Other Study ID Numbers: NN1998-1540
Study First Received: January 25, 2007
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
Glimepiride
Rosiglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 19, 2014