DiabetesPhase 2NCT01508949
Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes
A Phase 2 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide. 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?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2001to Mar 2002
- Phase
- Phase 2
- 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 mellitus
- Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
- HbA1c for diet treated subjects 6.5-12%, both inclusive
- HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
- Body mass index (BMI) at least 27 kg/m^2
- Euthyroid subjects
- Fasting blood glucose 7-14 mmol/l
Who cannot join
- Impaired liver function
- Impaired renal function
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Recurrent severe hypoglycaemia as judged by the Investigator
- Known or suspected allergy to trial product or related products
- Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes
This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.
- 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
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
placeboDrug
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| NNC 90-1170 | Experimental | Not described Receives: Drug: liraglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Secondary outcomes (8)
Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)
Waist circumference
Spontaneous energy intake assessed in connection to the ad libitum lunch meal
Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))
Gastric emptying rate
Energy expenditure
HbA1c (Glycosylated Haemoglobin)
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJun 2001
- Primary completionMar 2002
- Study completionMar 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 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
- NCT01508949
- Sponsor's protocol ID
- NN2211-1333
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2012
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1915-21. doi: 10.2337/diacare.27.8.1915.
PubMed 15277417
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01508949
- Acronym / sponsor ID
- NN2211-1333
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Mar 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 12 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 Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC 90-1170 | Experimental | Drug: liraglutide |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes mellitus
- Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
- HbA1c for diet treated subjects 6.5-12%, both inclusive
- HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
- Body mass index (BMI) at least 27 kg/m^2
Key exclusion criteria (7 listed)
- Impaired liver function
- Impaired renal function
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Recurrent severe hypoglycaemia as judged by the Investigator
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 90-1170Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously | Drug | NNC 90-1170 |
| placeboOnce daily dosing of 0.6 mg for 8 weeks, injected subcutaneously | Drug | Placebo |
Primary outcome
Change in weight
8 secondary outcomes
Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)
Waist circumference
Spontaneous energy intake assessed in connection to the ad libitum lunch meal
Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))
Gastric emptying rate
Energy expenditure
HbA1c (Glycosylated Haemoglobin)
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 2 Nov 2023.
- Results publication: PubMed 15277417Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1915-21. doi: 10.2337/diacare.27.8.1915.
- 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 2 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
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 7 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 2 Nov 2023. 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in weight. 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 NCT01508949, 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 2 Nov 2023.