DiabetesPhase 1NCT01511185
Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group
A Phase 1 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
- Body Mass Index (BMI): 24-35 kg/m^2 inclusive
Who cannot join
- SUBJECTS WITH TYPE 2 DIABETES
- Receipt of any investigational drug within three months prior to this trial
- Recurrent severe hypoglycemia as judged by the investigator
- Cardiac disease
- Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
- Haemoglobin maximum 10 g/L
Show all 14Show fewer
- HbA1c above 12%
- Loss of more than 400 mL blood during the 3 months prior to trial start
- HEALTHY SUBJECTS
- Receipt of any investigational drug within 3 months prior to this trial
- Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
- Use of any drug that in the investigator's opinion could interfere with the blood glucose level
- Haemoglobin max. 10 g/L
- HbA1c at least 6%
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Ann Arbor, Michigan, 48109-0926
About this study
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
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, placebo
- 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.
liraglutideDrug
Also called NNC 90-1170
A single dose of 7.5 mcg/kg administered subcutaneously in random order
placeboDrug
A single dose administered subcutaneously in random order
| Study group | Role | What they receive |
|---|---|---|
| NNC 90-1170 | Experimental | Not described Receives: Drug: liraglutide; Drug: placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: liraglutide; Drug: placebo |
| Healthy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval
Secondary outcomes (5)
Slope of the mean ISR vs mean glucose
AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
Insulin Clearance
NNC 90-1 170 plasma concentration
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startFeb 2001
- Primary completionOct 2001
- Study completionOct 2001
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT01511185
- Sponsor's protocol ID
- NN2211-2063
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2012
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chang AM, Jakobsen G, Sturis J, Smith MJ, Bloem CJ, An B, Galecki A, Halter JB. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003 Jul;52(7):1786-91. doi: 10.2337/diabetes.52.7.1786.
PubMed 12829647
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. 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
- NCT01511185
- Acronym / sponsor ID
- NN2211-2063
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 18 Jan 2012 (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 the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC 90-1170 | Experimental | Drug: liraglutide, Drug: placebo |
| Placebo | Placebo comparator | Drug: liraglutide, Drug: placebo |
| Healthy | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
- Body Mass Index (BMI): 24-35 kg/m^2 inclusive
Key exclusion criteria (14 listed)
- SUBJECTS WITH TYPE 2 DIABETES
- Receipt of any investigational drug within three months prior to this trial
- Recurrent severe hypoglycemia as judged by the investigator
- Cardiac disease
- Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
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 |
|---|---|---|
| liraglutideAlso: NNC 90-1170A single dose of 7.5 mcg/kg administered subcutaneously in random order | Drug | NNC 90-1170, Placebo |
| placeboA single dose administered subcutaneously in random order | Drug | NNC 90-1170, Placebo |
Primary outcome
AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval
5 secondary outcomes
Slope of the mean ISR vs mean glucose
AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
Insulin Clearance
NNC 90-1 170 plasma concentration
Adverse events
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 26 Jan 2017.
- Results publication: PubMed 12829647Chang AM, Jakobsen G, Sturis J, Smith MJ, Bloem CJ, An B, Galecki A, Halter JB. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003 Jul;52(7):1786-91. doi: 10.2337/diabetes.52.7.1786.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S 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 2 inclusion and 14 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 26 Jan 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 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. Some participants in this study may receive a placebo. 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?
AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval. 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 NCT01511185, 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 26 Jan 2017.