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Completed

NCT Number: NCT01511692

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

1.8 mg/day injected subcutaneously for 4 weeks

Placebo

Drug

Liraglutide placebo, injected subcutaneously for 4 weeks

Glimepiride

Drug

Dose individually adjusted, administered orally for 4 weeks

Primary outcomes

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

Secondary outcomes

  1. The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10

  2. Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10

  3. Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10

  4. Total duration of eating at the buffet meal (satiation)

  5. Weight

  6. Waist circumference

  7. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 19, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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