DiabetesPhase 1NCT01511692
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
A Phase 1 study testing liraglutide and glimepiride 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 Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide and glimepiride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2005to Sep 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
- HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
- Body mass index (BMI) between 27-40 kg/m^2 (both inclusive)
- Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
- Euthyroid subjects
- Subjects should be unrestrained eaters
Who cannot join
- Recurrent severe hypoglycaemia
- Impaired liver function
- Impaired renal function
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Known or suspected allergy to trial products or related products
Show all 11Show fewer
- Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunodeficiency virus) antibodies
- Known or suspected abuse of alcohol or narcotics
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Novo Nordisk Investigational Site
Adelaide, South Australia, 5005
About this study
Official title: A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, placebo, glimepiride
- 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
1.8 mg/day injected subcutaneously for 4 weeks
placeboDrug
Liraglutide placebo, injected subcutaneously for 4 weeks
placeboDrug
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
glimepirideDrug
Dose individually adjusted, administered orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lira --> placebo | Experimental | Not described Receives: Drug: liraglutide; Drug: placebo |
| Placebo --> glim | Placebo comparator | Not described Receives: Drug: placebo; Drug: glimepiride |
| Glim --> lira | Active comparator | Not described Receives: Drug: liraglutide; Drug: glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Secondary outcomes (7)
The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Total duration of eating at the buffet meal (satiation)
Weight
Waist circumference
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionSep 2007
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
- 43 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
- NCT01511692
- Sponsor's protocol ID
- NN2211-1589
- Other IDs
- 2006-000377-30
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2012
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24.
PubMed 22446097
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo
- ClinicalTrials.gov ID
- NCT01511692
- Acronym / sponsor ID
- NN2211-1589
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 19 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 and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake 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 |
|---|---|---|
| Lira --> placebo | Experimental | Drug: liraglutide, Drug: placebo |
| Placebo --> glim | Placebo comparator | Drug: placebo, Drug: glimepiride |
| Glim --> lira | Active comparator | Drug: liraglutide, Drug: glimepiride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes mellitus
- Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
- HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
- Body mass index (BMI) between 27-40 kg/m^2 (both inclusive)
- Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
Key exclusion criteria (11 listed)
- Recurrent severe hypoglycaemia
- Impaired liver function
- Impaired renal function
- Cardiac problems
- Uncontrolled treated/untreated hypertension
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 |
|---|---|---|
| liraglutide1.8 mg/day injected subcutaneously for 4 weeks | Drug | Glim --> lira, Lira --> placebo |
| placeboLiraglutide placebo, injected subcutaneously for 4 weeks | Drug | Lira --> placebo |
| placeboGlimepiride placebo, dose individually adjusted, administered orally for 4 weeks | Drug | Placebo --> glim |
| glimepirideDose individually adjusted, administered orally for 4 weeks | Drug | Glim --> lira, Placebo --> glim |
Primary outcome
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
7 secondary outcomes
The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Total duration of eating at the buffet meal (satiation)
Weight
Waist circumference
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 25 Jan 2017.
- Results publication: PubMed 22446097Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24.
- 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 liraglutide and glimepiride 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 7 inclusion and 11 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 25 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 2 sites in Australia, 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. 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?
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10. 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 NCT01511692, 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 25 Jan 2017.