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

NCT00348712 | Terminated Phase 3

• 2 other identifiers: NN1998-13902006-000796-15
• Study Type: interventional
• Target: 301
• Locations: 9 countries
• Sites: 74

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).

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Treatment difference in HbA1c

  After 26 weeks

Secondary Outcomes (5)

• Adverse events

  For the duration of the trial

• Body weight

  For the duration of the trial

• Lung function

  For the duration of the trial

• Blood glucose

  For the duration of the trial

• Hypoglycaemia

  For the duration of the trial

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: inhaled human insulin; Drug: metformin

B

ACTIVE COMPARATOR

Drug: rosiglitazone; Drug: metformin

Interventions

rosiglitazone DRUG

Tablets, 4 mg once or twice daily.

B

inhaled human insulin DRUG

Treat-to-target dose titration scheme, inhalation.

Also known as: NN1998

A

metformin DRUG

Tablets, 2000 mg/day.

A; B

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (74)

Novo Nordisk Investigational Site

Ebreichsdorf, 2483, Austria

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Novo Nordisk Investigational Site

Vienna, 1030, Austria

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Novo Nordisk Investigational Site

Vienna, 1090, Austria

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Novo Nordisk Investigational Site

Joensuu, 80130, Finland

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Novo Nordisk Investigational Site

Kirkkonummi, 02400, Finland

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Novo Nordisk Investigational Site

Turku, FI-20520, Finland

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Novo Nordisk Investigational Site

Corbeil-Essonnes, 91106, France

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Novo Nordisk Investigational Site

La Rochelle, 17019, France

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Novo Nordisk Investigational Site

Mougins, 06250, France

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Novo Nordisk Investigational Site

Nanterre, 92014, 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

Pessac, 33600, France

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Novo Nordisk Investigational Site

Pointe à Pitre, 97159, France

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Novo Nordisk Investigational Site

Roubaix, 59100, France

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Novo Nordisk Investigational Site

Tours, 37044, France

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Novo Nordisk Investigational Site

Vénissieux, 69200, France

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Novo Nordisk Investigational Site

Aschaffenburg, 63739, Germany

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Augsburg, 86150, Germany

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Bad Mergentheim, 97980, Germany

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Berlin, 13355, Germany

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Darmstadt, 64283, Germany

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Dormagen, 41539, Germany

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Dresden, 01307, Germany

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Duisburg, 47051, Germany

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Flörsheim, 65439, Germany

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Frankfurt, 60590, Germany

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Fulda, 36037, Germany

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Genthin, 39307, Germany

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Hermaringen, 89568, Germany

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Kutenholz-Mulsum, 27449, Germany

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Münster, 48145, Germany

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Pirna, 01796, Germany

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Novo Nordisk Investigational Site

Schkeuditz, 04435, Germany

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Novo Nordisk Investigational Site

Wangen, 88239, Germany

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Novo Nordisk Investigational Site

Wiesbaden, 65191, Germany

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Novo Nordisk Investigational Site

Dublin, DUBLIN 7, Ireland

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Dublin, DUBLIN 8, Ireland

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Novo Nordisk Investigational Site

Waterford, Ireland

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Novo Nordisk Investigational Site

Delft, 2625 AD, Netherlands

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Novo Nordisk Investigational Site

Drachten, 9202 NN, Netherlands

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Novo Nordisk Investigational Site

Rijswijk, 2281 AK, Netherlands

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Novo Nordisk Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

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Novo Nordisk Investigational Site

The Hague, 2582 LJ, Netherlands

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Novo Nordisk Investigational Site

The Hague, 2597 AX, Netherlands

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Novo Nordisk Investigational Site

Vlodrop, 6063 DA, Netherlands

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Novo Nordisk Investigational Site

Zwijndrecht, 3331 LZ, Netherlands

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Novo Nordisk Investigational Site

Alzira, 46600, Spain

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Novo Nordisk Investigational Site

Barcelona, 08035, Spain

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Novo Nordisk Investigational Site

Gijón, 33206, Spain

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Novo Nordisk Investigational Site

Majadahonda, 28222, Spain

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Novo Nordisk Investigational Site

Palma de Mallorca, 07010, Spain

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Novo Nordisk Investigational Site

Partida de Bacarot, 03114, Spain

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Novo Nordisk Investigational Site

Pontevedra, 36071, Spain

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Novo Nordisk Investigational Site

Reus, 43201, Spain

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Novo Nordisk Investigational Site

San Juan, 03550, Spain

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Novo Nordisk Investigational Site

Seville, 41009, Spain

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Novo Nordisk Investigational Site

Interlaken-Unterseen, 3800, Switzerland

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Novo Nordisk Investigational Site

Olten, 4600, Switzerland

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Novo Nordisk Investigational Site

Zurich, 8032, Switzerland

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Novo Nordisk Investigational Site

Aberdeen, AB25 1LD, United Kingdom

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Novo Nordisk Investigational Site

Bath, BA1 2SR, United Kingdom

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Novo Nordisk Investigational Site

Belfast, BT12 6BA, United Kingdom

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Novo Nordisk Investigational Site

Birmingham, B9 5SS, United Kingdom

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Novo Nordisk Investigational Site

Bradford-on-Avon, BA15 1DQ, United Kingdom

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Novo Nordisk Investigational Site

Guildford, GU2 7XX, United Kingdom

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Novo Nordisk Investigational Site

Hull, HU3 2JZ, United Kingdom

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Novo Nordisk Investigational Site

Northampton, NN1 5BD, United Kingdom

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Novo Nordisk Investigational Site

Salford, M6 8HD, United Kingdom

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Novo Nordisk Investigational Site

Swansea, SA6 6NL, United Kingdom

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Novo Nordisk Investigational Site

Trowbridge, BA14 8QA, United Kingdom

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Novo Nordisk Investigational Site

Trowbridge, BA14 9AR, United Kingdom

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Novo Nordisk Investigational Site

Wirral, Merseyside, CH63 4JY, United Kingdom

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Novo Nordisk Investigational Site

York, YO3 7HE, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Rosiglitazone; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

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: July 5, 2006
• First Posted: July 6, 2006
• Study Start: October 30, 2006
• Primary Completion: March 5, 2008
• Study Completion: March 5, 2008
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

DE (19); CH (3); ES (10); AU (3); FI (3); GB (14); FR (11); NL (8); IE (3)