DiabetesPhase 1NCT00400283
A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes
A Phase 1 study testing NNC 55-0414 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- NNC 55-0414
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jan 2001to 3 May 2001
- Phase
- Phase 1
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Diet treatment only for at least two weeks
- Body mass index (BMI) between 22-34 kg/m2 inclusive
- HbA1C between 6.5-12.0% inclusive
- Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
- Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD)
Who cannot join
- Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
- History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
- Impaired renal function, serum creatinine greater than 150µmol/L
- Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
- Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
- Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks
- Patients who had a significant history of alcoholism or drug/chemical abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes
This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- NNC 55-0414
- 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.
NNC 55-0414Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study start19 Jan 2001
- Primary completion3 May 2001
- Study completion3 May 2001
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 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
- NCT00400283
- Sponsor's protocol ID
- NN414-1384
- Status last verified
- Feb 2017
- First submitted
- 15 Nov 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00400283
- Acronym / sponsor ID
- NN414-1384
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2001 (actual)
- Primary completion
- 3 May 2001 (actual)
- Study completion
- 3 May 2001 (actual)
- First posted
- 16 Nov 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. A seven day dose escalation study in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- Diet treatment only for at least two weeks
- Body mass index (BMI) between 22-34 kg/m2 inclusive
- HbA1C between 6.5-12.0% inclusive
- Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
Key exclusion criteria (7 listed)
- Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
- History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
- Impaired renal function, serum creatinine greater than 150µmol/L
- Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
- Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
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 |
|---|---|---|
| NNC 55-0414 | Drug | – |
Primary outcome
To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC 55-0414 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.. 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 24 Feb 2017.