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Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

NCT ID: NCT00469586

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-26

Study Completion Date

2008-04-24

Brief Summary

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This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

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Detailed Description

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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.

Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, pre-prandial, inhalation.

B

Group Type EXPERIMENTAL

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, post-prandial, inhalation.

C

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

Tablets, 2000 mg/day.

glimepiride

Intervention Type DRUG

Tablets, 4 mg/day.

Interventions

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inhaled human insulin

Treat-to-target dose titration scheme, pre-prandial, inhalation.

Intervention Type DRUG

metformin

Tablets, 2000 mg/day.

Intervention Type DRUG

glimepiride

Tablets, 4 mg/day.

Intervention Type DRUG

inhaled human insulin

Treat-to-target dose titration scheme, post-prandial, inhalation.

Intervention Type DRUG

Other Intervention Names

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NN1998 NN1998

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Treated with OADs for more than or equal to 3 months
* HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria

* Recurrent major hypoglycaemia
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Proliferative retinopathy or maculopathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Mar del Plata, , Argentina

Site Status

Novo Nordisk Investigational Site

Mendoza, , Argentina

Site Status

Novo Nordisk Investigational Site

Ebreichsdorf, , Austria

Site Status

Novo Nordisk Investigational Site

Kittsee, , Austria

Site Status

Novo Nordisk Investigational Site

Salzburg, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Arlon, , Belgium

Site Status

Novo Nordisk Investigational Site

Bonheiden, , Belgium

Site Status

Novo Nordisk Investigational Site

Borsbeek, , Belgium

Site Status

Novo Nordisk Investigational Site

Ghent, , Belgium

Site Status

Novo Nordisk Investigational Site

Huy, , Belgium

Site Status

Novo Nordisk Investigational Site

Leuven, , Belgium

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Smiths Falls, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Laval, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Mississauga, , Canada

Site Status

Novo Nordisk Investigational Site

Oshawa, , Canada

Site Status

Novo Nordisk Investigational Site

Saskatoon, , Canada

Site Status

Novo Nordisk Investigational Site

Trois-Rivières, , Canada

Site Status

Novo Nordisk Investigational Site

Corbeil-Essonnes, , France

Site Status

Novo Nordisk Investigational Site

Nantes, , France

Site Status

Novo Nordisk Investigational Site

Narbonne, , France

Site Status

Novo Nordisk Investigational Site

Nevers, , France

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Roubaix, , France

Site Status

Novo Nordisk Investigational Site

Indore, Madhya Pradesh, India

Site Status

Novo Nordisk Investigational Site

Bangalore, , India

Site Status

Novo Nordisk Investigational Site

Coimbatore, , India

Site Status

Novo Nordisk Investigational Site

Hyderabad, , India

Site Status

Novo Nordisk Investigational Site

Thriruvananthapuram, , India

Site Status

Novo Nordisk Investigational Site

Beersheba, , Israel

Site Status

Novo Nordisk Investigational Site

Holon, , Israel

Site Status

Novo Nordisk Investigational Site

Jerusalem, , Israel

Site Status

Novo Nordisk Investigational Site

Mexico City, México, D.F., Mexico

Site Status

Novo Nordisk Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Novo Nordisk Investigational Site

Guadalajara, , Mexico

Site Status

Novo Nordisk Investigational Site

Mexico City, , Mexico

Site Status

Novo Nordisk Investigational Site

Mexico City, , Mexico

Site Status

Novo Nordisk Investigational Site

Gdansk, , Poland

Site Status

Novo Nordisk Investigational Site

Lodz, , Poland

Site Status

Novo Nordisk Investigational Site

Lublin, , Poland

Site Status

Novo Nordisk Investigational Site

Lublin, , Poland

Site Status

Novo Nordisk Investigational Site

Mazowieckie, , Poland

Site Status

Novo Nordisk Investigational Site

Rawa Mazowiecka, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Zabrze, , Poland

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Konya, , Turkey (Türkiye)

Site Status

Countries

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Argentina Austria Belgium Bulgaria Canada France India Israel Mexico Poland Turkey (Türkiye)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-004623-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1998-1787

Identifier Type: -

Identifier Source: org_study_id

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