DiabetesPhase 1NCT00897169
A Trial Investigating the Possible Difference in Development of Type 2 Diabetes Between Caucasian and Japanese Subjects
A Phase 1 study testing Oral Glucose Tolerance Test (OGTT) and Euglycaemic hyperinsulinaemic clamp in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian population. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Oral Glucose Tolerance Test (OGTT) and Euglycaemic hyperinsulinaemic clamp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2009to Dec 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Danish (Northern European) or Japanese (according to country allocation) background for at least 3 generations
- BMI above or equal to 18 kg/m2
Who cannot join
- Treatment of diabetes mellitus with any insulin product
- Fasting plasma/serum glucose above 12 mM
- Therapy with TZD (thiazolidinedione) drugs within the past 3 months
- Therapy with more than 2 OADs (oral anti-diabetics drugs)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Trial Investigating the Possible Difference in the Development of Type 2 Diabetes in Caucasian and Japanese Subjects by a Model-based Analysis
This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects with type 2 diabetes will be included in the trial. The development of type 2 diabetes across the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Oral Glucose Tolerance Test (OGTT), Euglycaemic hyperinsulinaemic clamp
- 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.
Oral Glucose Tolerance Test (OGTT)Other
A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2
Euglycaemic hyperinsulinaemic clampOther
A 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Other: Oral Glucose Tolerance Test (OGTT) |
| B | Experimental | Not described Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: Euglycaemic hyperinsulinaemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell function index estimated by a model-based analysis fit to the complete OGTT C-peptide and glucose profiles (12 time points), and including diabetes progression (as assessed by the glucose concentration 2 hours after an oral glucose load)
Measured: At 5-hour Oral Glucose Tolerance Test (OGTT)
Secondary outcomes (3)
Insulin sensitivity estimated by a model-based analysis fit to the complete OGTT insulin and glucose profiles (12 time points)
Measured: At 5-hour OGTT and 4-hour clamp procedure
Fraction of the possible difference in ß-cell function and insulin sensitivity between Japanese and Caucasian that can be explained by each covariate factor
Measured: At 5-hour OGTT and 4-hour clamp procedure
Evaluation of comparability of OGTT and clamp data based on modelling data of insulin sensitivity from steady-state clamp insulin and glucose concentrations and OGTT insulin and glucose profiles (12 time points)
Measured: At 5-hour OGTT and 4-hour clamp procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 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
- NCT00897169
- Sponsor's protocol ID
- INS-3662
- Status last verified
- Oct 2016
- First submitted
- 24 Feb 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Moller JB, Pedersen M, Tanaka H, Ohsugi M, Overgaard RV, Lynge J, Almind K, Vasconcelos NM, Poulsen P, Keller C, Ueki K, Ingwersen SH, Pedersen BK, Kadowaki T. Body composition is the main determinant for the difference in type 2 diabetes pathophysiology between Japanese and Caucasians. Diabetes Care. 2014;37(3):796-804. doi: 10.2337/dc13-0598. Epub 2013 Oct 15.
PubMed 24130359
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Possible Difference in the Development of Type 2 Diabetes in Caucasian and Japanese Subjects by a Model-based Analysis
- ClinicalTrials.gov ID
- NCT00897169
- Acronym / sponsor ID
- INS-3662
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 May 2009 (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 and Japan. The aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects with type 2 diabetes will be included in the trial. The development of type 2 diabetes across the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Oral Glucose Tolerance Test (OGTT) |
| B | Experimental | Other: Oral Glucose Tolerance Test (OGTT), Other: Euglycaemic hyperinsulinaemic clamp |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Danish (Northern European) or Japanese (according to country allocation) background for at least 3 generations
- BMI above or equal to 18 kg/m2
Key exclusion criteria (4 listed)
- Treatment of diabetes mellitus with any insulin product
- Fasting plasma/serum glucose above 12 mM
- Therapy with TZD (thiazolidinedione) drugs within the past 3 months
- Therapy with more than 2 OADs (oral anti-diabetics drugs)
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 |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT)A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2 | Other | A, B |
| Euglycaemic hyperinsulinaemic clampA 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3 | Other | B |
Primary outcome
Beta-cell function index estimated by a model-based analysis fit to the complete OGTT C-peptide and glucose profiles (12 time points), and including diabetes progression (as assessed by the glucose concentration 2 hours after an oral glucose load)
Time frame: At 5-hour Oral Glucose Tolerance Test (OGTT)
3 secondary outcomes
Insulin sensitivity estimated by a model-based analysis fit to the complete OGTT insulin and glucose profiles (12 time points)
Time frame: At 5-hour OGTT and 4-hour clamp procedure
Fraction of the possible difference in ß-cell function and insulin sensitivity between Japanese and Caucasian that can be explained by each covariate factor
Time frame: At 5-hour OGTT and 4-hour clamp procedure
Evaluation of comparability of OGTT and clamp data based on modelling data of insulin sensitivity from steady-state clamp insulin and glucose concentrations and OGTT insulin and glucose profiles (12 time points)
Time frame: At 5-hour OGTT and 4-hour clamp procedure
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 27 Oct 2016.
- Derived from this study: PubMed 24130359Moller JB, Pedersen M, Tanaka H, Ohsugi M, Overgaard RV, Lynge J, Almind K, Vasconcelos NM, Poulsen P, Keller C, Ueki K, Ingwersen SH, Pedersen BK, Kadowaki T. Body composition is the main determinant for the difference in type 2 diabetes pathophysiology between Japanese and Caucasians. Diabetes Care. 2014;37(3):796-804. doi: 10.2337/dc13-0598. Epub 2013 Oct 15.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Glucose Tolerance Test (OGTT) and Euglycaemic hyperinsulinaemic clamp in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 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 2 inclusion and 4 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Japan. 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?
Beta-cell function index estimated by a model-based analysis fit to the complete OGTT C-peptide and glucose profiles (12 time points), and including diabetes progression (as assessed by the glucose concentration 2 hours after an oral glucose load) (time frame: At 5-hour Oral Glucose Tolerance Test (OGTT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00897169, which also lists 1 linked publication.
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 27 Oct 2016.