Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
NCT ID: NCT01511692
Last Updated: 2017-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2005-11-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Lira --> placebo
liraglutide
1.8 mg/day injected subcutaneously for 4 weeks
placebo
Liraglutide placebo, injected subcutaneously for 4 weeks
Placebo --> glim
placebo
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
glimepiride
Dose individually adjusted, administered orally for 4 weeks
Glim --> lira
liraglutide
1.8 mg/day injected subcutaneously for 4 weeks
glimepiride
Dose individually adjusted, administered orally for 4 weeks
Interventions
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liraglutide
1.8 mg/day injected subcutaneously for 4 weeks
placebo
Liraglutide placebo, injected subcutaneously for 4 weeks
placebo
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
glimepiride
Dose individually adjusted, administered orally for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Known or suspected allergy to trial products or related products
* 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
18 Years
65 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Adelaide, South Australia, Australia
Novo Nordisk Investigational Site
Neuss, , Germany
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-000377-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN2211-1589
Identifier Type: -
Identifier Source: org_study_id
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