Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01511692




Registration number
NCT01511692
Ethics application status
Date submitted
12/01/2012
Date registered
19/01/2012
Date last updated
25/01/2017

Titles & IDs
Public title
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
Scientific 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
Secondary ID [1] 0 0
2006-000377-30
Secondary ID [2] 0 0
NN2211-1589
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Treatment: Drugs - glimepiride

Experimental: Lira --> placebo -

Placebo comparator: Placebo --> glim -

Active comparator: Glim --> lira -


Treatment: Drugs: liraglutide
1.8 mg/day injected subcutaneously for 4 weeks

Treatment: Drugs: placebo
Liraglutide placebo, injected subcutaneously for 4 weeks

Treatment: Drugs: placebo
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks

Treatment: Drugs: glimepiride
Dose individually adjusted, administered orally for 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Total duration of eating at the buffet meal (satiation)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Weight
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Waist circumference
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Adverse events
Timepoint [7] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5005 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Neuss

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Horowitz M, Flint A, Jones KL, Hindsberger C, Rasm... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01511692