DiabetesPhase 3NCT00348712
Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
A Phase 3 study testing rosiglitazone, inhaled human insulin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 74 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- rosiglitazone, inhaled human insulin and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 74 sitesin 9 countries
- Study dates
- 30 Oct 2006to 5 Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
74 sites in 9 countries.
74 sites in 9 countries
Germany19 sites
Novo Nordisk Investigational Site
Aschaffenburg, 63739
Novo Nordisk Investigational Site
Augsburg, 86150
Novo Nordisk Investigational Site
Bad Mergentheim, 97980
Novo Nordisk Investigational Site
Berlin, 13355
Novo Nordisk Investigational Site
Darmstadt, 64283
Novo Nordisk Investigational Site
Dormagen, 41539
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Flörsheim, 65439
Novo Nordisk Investigational Site
Frankfurt, 60590
Novo Nordisk Investigational Site
Fulda, 36037
Novo Nordisk Investigational Site
Genthin, 39307
Novo Nordisk Investigational Site
Hermaringen, 89568
Novo Nordisk Investigational Site
Kutenholz-Mulsum, 27449
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Pirna, 01796
Novo Nordisk Investigational Site
Schkeuditz, 04435
Novo Nordisk Investigational Site
Wangen, 88239
Novo Nordisk Investigational Site
Wiesbaden, 65191
United Kingdom14 sites
Novo Nordisk Investigational Site
Aberdeen, AB25 1LD
Novo Nordisk Investigational Site
Bath, BA1 2SR
Novo Nordisk Investigational Site
Belfast, BT12 6BA
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Bradford on Avon, BA15 1DQ
Novo Nordisk Investigational Site
Guildford, GU2 7XX
Novo Nordisk Investigational Site
Hull, HU3 2JZ
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Salford, M6 8HD
Novo Nordisk Investigational Site
Swansea, SA6 6NL
Novo Nordisk Investigational Site
Trowbridge, BA14 8QA
Novo Nordisk Investigational Site
Trowbridge, BA14 9AR
Novo Nordisk Investigational Site
Wirral, Merseyside, CH63 4JY
Novo Nordisk Investigational Site
York, YO3 7HE
France11 sites
Novo Nordisk Investigational Site
Corbeil-Essonnes, 91106
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Pessac, 33600
Novo Nordisk Investigational Site
Pointe à Pitre, 97159
Novo Nordisk Investigational Site
Roubaix, 59100
Novo Nordisk Investigational Site
Tours, 37044
Novo Nordisk Investigational Site
Vénissieux, 69200
Spain10 sites
Novo Nordisk Investigational Site
Alzira, 46600
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Gijón, 33206
Novo Nordisk Investigational Site
Majadahonda, 28222
Novo Nordisk Investigational Site
Palma de Mallorca, 07010
Novo Nordisk Investigational Site
Partida de Bacarot, 03114
Novo Nordisk Investigational Site
Pontevedra, 36071
Novo Nordisk Investigational Site
Reus, 43201
Novo Nordisk Investigational Site
San Juan, 03550
Novo Nordisk Investigational Site
Seville, 41009
Netherlands8 sites
Novo Nordisk Investigational Site
Delft, 2625 AD
Novo Nordisk Investigational Site
Drachten, 9202 NN
Novo Nordisk Investigational Site
Rijswijk, 2281 AK
Novo Nordisk Investigational Site
Roelofarendsveen, 2371 RB
Novo Nordisk Investigational Site
The Hague, 2582 LJ
Novo Nordisk Investigational Site
The Hague, 2597 AX
Novo Nordisk Investigational Site
Vlodrop, 6063 DA
Novo Nordisk Investigational Site
Zwijndrecht, 3331 LZ
Austria3 sites
Novo Nordisk Investigational Site
Ebreichsdorf, 2483
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1090
Finland3 sites
Novo Nordisk Investigational Site
Joensuu, 80130
Novo Nordisk Investigational Site
Kirkkonummi, 02400
Novo Nordisk Investigational Site
Turku, FI-20520
Ireland3 sites
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Waterford
Switzerland3 sites
Novo Nordisk Investigational Site
Interlaken-Unterseen, 3800
Novo Nordisk Investigational Site
Olten, 4600
Novo Nordisk Investigational Site
Zurich, 8032
About this study
Official title: Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
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).
Read the 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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- rosiglitazone, inhaled human insulin, metformin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
Tablets, 4 mg once or twice daily.
inhaled human insulinDrug
Also called NN1998
Treat-to-target dose titration scheme, inhalation.
metforminDrug
Tablets, 2000 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: inhaled human insulin; Drug: metformin |
| B | Active comparator | Not described Receives: Drug: rosiglitazone; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment difference in HbA1c
Measured: After 26 weeks
Secondary outcomes (5)
Adverse events
Measured: For the duration of the trial
Body weight
Measured: For the duration of the trial
Lung function
Measured: For the duration of the trial
Blood glucose
Measured: For the duration of the trial
Hypoglycaemia
Measured: For the duration of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study start30 Oct 2006
- Primary completion5 Mar 2008
- Study completion5 Mar 2008
Why it stopped: See termination reason in detailed description
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348712
- Sponsor's protocol ID
- NN1998-1390
- Other IDs
- 2006-000796-15
- Status last verified
- Feb 2017
- First submitted
- 5 Jul 2006
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00348712
- Acronym / sponsor ID
- NN1998-1390
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2006 (actual)
- Primary completion
- 5 Mar 2008 (actual)
- Study completion
- 5 Mar 2008 (actual)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: inhaled human insulin, Drug: metformin |
| B | Active comparator | Drug: rosiglitazone, Drug: metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Recurrent major hypoglycaemia
- Current smoking or smoking within the last 6 months
- Impaired hepatic or renal function
- Cardiac disorders
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazoneTablets, 4 mg once or twice daily. | Drug | B |
| inhaled human insulinAlso: NN1998Treat-to-target dose titration scheme, inhalation. | Drug | A |
| metforminTablets, 2000 mg/day. | Drug | A, B |
Primary outcome
Treatment difference in HbA1c
Time frame: After 26 weeks
5 secondary outcomes
Adverse events
Time frame: For the duration of the trial
Body weight
Time frame: For the duration of the trial
Lung function
Time frame: For the duration of the trial
Blood glucose
Time frame: For the duration of the trial
Hypoglycaemia
Time frame: For the duration of the trial
Results and safety
The study was stopped early (reason given: See termination reason in detailed description). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
74 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rosiglitazone, inhaled human insulin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 74 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Germany, United Kingdom, France, Spain, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment difference in HbA1c (time frame: After 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.