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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
liraglutide
placebo
placebo
glimepiride
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Lira --> placebo

Placebo --> glim

Glim --> lira

Arm Description

Outcomes

Primary Outcome Measures

The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2012
Last Updated
January 24, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01511692
Brief Title
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lira --> placebo
Arm Type
Experimental
Arm Title
Placebo --> glim
Arm Type
Placebo Comparator
Arm Title
Glim --> lira
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
1.8 mg/day injected subcutaneously for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Liraglutide placebo, injected subcutaneously for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
Dose individually adjusted, administered orally for 4 weeks
Primary Outcome Measure Information:
Title
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Secondary Outcome Measure Information:
Title
The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Title
Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Title
Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Title
Total duration of eating at the buffet meal (satiation)
Title
Weight
Title
Waist circumference
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5005
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22446097
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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