- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01511692
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
January 24, 2017 updated by: Novo Nordisk A/S
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lira --> placebo
|
1.8 mg/day injected subcutaneously for 4 weeks
Liraglutide placebo, injected subcutaneously for 4 weeks
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
|
Placebo Comparator: Placebo --> glim
|
Liraglutide placebo, injected subcutaneously for 4 weeks
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
Dose individually adjusted, administered orally for 4 weeks
|
Active Comparator: Glim --> lira
|
1.8 mg/day injected subcutaneously for 4 weeks
Dose individually adjusted, administered orally for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events
|
Weight
|
Waist circumference
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
January 12, 2012
First Submitted That Met QC Criteria
January 18, 2012
First Posted (Estimate)
January 19, 2012
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Anti-Arrhythmia Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Liraglutide
- Glimepiride
Other Study ID Numbers
- NN2211-1589
- 2006-000377-30 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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