Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

NCT ID: NCT01511692

Last Updated: 2017-01-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lira --> placebo

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

1.8 mg/day injected subcutaneously for 4 weeks

placebo

Intervention Type DRUG

Liraglutide placebo, injected subcutaneously for 4 weeks

Placebo --> glim

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks

glimepiride

Intervention Type DRUG

Dose individually adjusted, administered orally for 4 weeks

Glim --> lira

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

1.8 mg/day injected subcutaneously for 4 weeks

glimepiride

Intervention Type DRUG

Dose individually adjusted, administered orally for 4 weeks

Interventions

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liraglutide

1.8 mg/day injected subcutaneously for 4 weeks

Intervention Type DRUG

placebo

Liraglutide placebo, injected subcutaneously for 4 weeks

Intervention Type DRUG

placebo

Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks

Intervention Type DRUG

glimepiride

Dose individually adjusted, administered orally for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Novo Nordisk Investigational Site

Neuss, , Germany

Site Status

Countries

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Australia Germany

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.

Reference Type RESULT
PMID: 22446097 (View on PubMed)

Related Links

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http://novonordisk-trials.com

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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