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

NCT00469586 | Terminated Phase 3

• 2 other identifiers: NN1998-17872006-004623-12
• Study Type: interventional
• Target: 174
• Locations: 11 countries
• Sites: 59

Brief Summary

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).

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline

  After 18 weeks of treatment

Secondary Outcomes (5)

• Adverse events

  For the duration of the trial

• Body weight

  after 18 weeks of treatment

• Lung function

  after 18 weeks of treatment

• Blood glucose

  after 18 weeks of treatment

• Hypoglycaemia

  after 18 weeks of treatment

Study Arms (3)

A

EXPERIMENTAL

Drug: inhaled human insulin

B

EXPERIMENTAL

Drug: inhaled human insulin

C

ACTIVE COMPARATOR

Drug: metformin; Drug: glimepiride

Interventions

inhaled human insulin DRUG

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

Also known as: NN1998

A

metformin DRUG

Tablets, 2000 mg/day.

C

glimepiride DRUG

Tablets, 4 mg/day.

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (59)

Novo Nordisk Investigational Site

Buenos Aires, B1636DSU, Argentina

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Novo Nordisk Investigational Site

Buenos Aires, C1425AGC, Argentina

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Novo Nordisk Investigational Site

Mar del Plata, B7600FZN, Argentina

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Novo Nordisk Investigational Site

Mendoza, 5500, Argentina

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Novo Nordisk Investigational Site

Ebreichsdorf, 2483, Austria

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Novo Nordisk Investigational Site

Kittsee, A 2421, Austria

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Novo Nordisk Investigational Site

Salzburg, 5020, Austria

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Novo Nordisk Investigational Site

Vienna, 1130, Austria

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Novo Nordisk Investigational Site

Vienna, A 1160, Austria

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Novo Nordisk Investigational Site

Arlon, 6700, Belgium

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Novo Nordisk Investigational Site

Bonheiden, 2820, Belgium

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Novo Nordisk Investigational Site

Borsbeek, 2150, Belgium

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Novo Nordisk Investigational Site

Ghent, 9000, Belgium

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Novo Nordisk Investigational Site

Huy, 4500, Belgium

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Novo Nordisk Investigational Site

Leuven, 3000, Belgium

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Novo Nordisk Investigational Site

Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Novo Nordisk Investigational Site

Edmonton, Alberta, T5J 3N4, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Novo Nordisk Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

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Novo Nordisk Investigational Site

Hamilton, Ontario, L8L 2X2, Canada

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Novo Nordisk Investigational Site

Smiths Falls, Ontario, K7A 4W8, Canada

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Novo Nordisk Investigational Site

Laval, Quebec, H7T 2P5, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Novo Nordisk Investigational Site

Mississauga, L5M 2V8, Canada

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Oshawa, L1J 2K1, Canada

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Novo Nordisk Investigational Site

Saskatoon, S7N 0W8, Canada

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Novo Nordisk Investigational Site

Trois-Rivières, G8T 7A1, Canada

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Novo Nordisk Investigational Site

Corbeil-Essonnes, 91106, France

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Novo Nordisk Investigational Site

Nantes, 44093, France

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Novo Nordisk Investigational Site

Narbonne, 11108, France

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Novo Nordisk Investigational Site

Nevers, 58033, France

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Novo Nordisk Investigational Site

Paris, 75877, France

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Novo Nordisk Investigational Site

Roubaix, 59100, France

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Novo Nordisk Investigational Site

Indore, Madhya Pradesh, 452010, India

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Novo Nordisk Investigational Site

Bangalore, 560041, India

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Novo Nordisk Investigational Site

Coimbatore, 641002, India

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Novo Nordisk Investigational Site

Hyderabad, 600034, India

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Novo Nordisk Investigational Site

Thriruvananthapuram, 695 032, India

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Novo Nordisk Investigational Site

Beersheba, 84101, Israel

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Novo Nordisk Investigational Site

Holon, 58100, Israel

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Novo Nordisk Investigational Site

Jerusalem, 91120, Israel

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Novo Nordisk Investigational Site

Mexico City, México, D.F., 14000, Mexico

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Novo Nordisk Investigational Site

Monterrey, Nuevo León, 64460, Mexico

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Novo Nordisk Investigational Site

Guadalajara, 44600, Mexico

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Novo Nordisk Investigational Site

Mexico City, 03100, Mexico

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Novo Nordisk Investigational Site

Mexico City, 11650, Mexico

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Novo Nordisk Investigational Site

Gdansk, 80-858, Poland

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Novo Nordisk Investigational Site

Lodz, 90-030, Poland

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Novo Nordisk Investigational Site

Lublin, 20-044, Poland

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Novo Nordisk Investigational Site

Lublin, 20-538, Poland

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Novo Nordisk Investigational Site

Mazowieckie, 09-400, Poland

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Novo Nordisk Investigational Site

Rawa Mazowiecka, 96-200, Poland

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Novo Nordisk Investigational Site

Warsaw, 02-097, Poland

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Novo Nordisk Investigational Site

Zabrze, 41-800, Poland

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Novo Nordisk Investigational Site

Istanbul, 34093, Turkey (Türkiye)

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Novo Nordisk Investigational Site

Istanbul, 34371, Turkey (Türkiye)

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Novo Nordisk Investigational Site

Istanbul, 34718, Turkey (Türkiye)

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Novo Nordisk Investigational Site

Konya, 42001, Turkey (Türkiye)

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Metformin; glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: April 26, 2007
• Primary Completion: April 24, 2008
• Study Completion: April 24, 2008
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

PL (8); IN (5); BU (2); FR (6); AR (4); ME (5); BE (6); CA (11); TU (4); AU (5); IL (3)