Diabetes Mellitus, Non-Insulin-DependentPhase 1NCT00013910
NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
A Phase 1 study testing NNC 90-1170 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- NNC 90-1170
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Type 2 Diabetes
- Signed and dated informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
- Subjects diagnosed with type 2 diabetes according to the American Diabetes Association (ADA) criteria (6): fasting plasma glucose ?126 mg/dL (7.0 mmol/L) or 2-hour plasma glucose ? 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT).
- Subjects with type 2 diabetes either newly diagnosed with at least 2 months of diet or on oral anti-diabetic monotherapy for at least 3 months.
- Age 30-75 years inclusive. Body Mass Index 24 to 35 kg/m2 inclusive.
- Healthy Volunteers
Show all 9Show fewer
- The subject must give signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
- Age 30-75 years inclusive.
- Body Mass Index 24 to 35 kg/m2 inclusive. Must meet the ADA criteria for normal glucose tolerance (6): fasting plasma glucose below 110 mg/dL (6.1 mmol/L) and 2-hour plasma glucose < 140 mg/mL (7.8 mmol/L) during an OGTT.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes.
NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn.
Read more
One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly).
The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over.
The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- NNC 90-1170
- Keywords
- glucagon-like peptide 1
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC 90-1170Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013910
- Sponsor's protocol ID
- NCRR-M01RR00042-1749
- Status last verified
- Nov 2001
- First submitted
- 2 Apr 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00013910
- Acronym / sponsor ID
- NCRR-M01RR00042-1749
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- glucagon-like peptide 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 3 Apr 2001 (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.
The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes.
NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn.
One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly).
The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over.
The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with Type 2 Diabetes
- Signed and dated informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
- Subjects diagnosed with type 2 diabetes according to the American Diabetes Association (ADA) criteria (6): fasting plasma glucose ?126 mg/dL (7.0 mmol/L) or 2-hour plasma glucose ? 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT).
- Subjects with type 2 diabetes either newly diagnosed with at least 2 months of diet or on oral anti-diabetic monotherapy for at least 3 months.
- Age 30-75 years inclusive. Body Mass Index 24 to 35 kg/m2 inclusive.
Key exclusion criteria (0 listed)
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 90-1170 | Drug | – |
Primary outcome
Not reported in the source record.
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 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 90-1170 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by National Center for Research Resources (NCRR) at 1 site in United States.
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 9 inclusion and 0 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 Jun 2005. 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 United States. 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.
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 Jun 2005.