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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01511692
First received: January 12, 2012
Last updated: August 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Drug: glimepiride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
  • Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
  • Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
  • Total duration of eating at the buffet meal (satiation) [ Designated as safety issue: No ]
  • Weight [ Designated as safety issue: No ]
  • Waist circumference [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: November 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira --> placebo Drug: liraglutide
1.8 mg/day injected subcutaneously for 4 weeks
Drug: placebo
Liraglutide placebo, injected subcutaneously for 4 weeks
Placebo Comparator: Placebo --> glim Drug: placebo
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
Drug: glimepiride
Dose individually adjusted, administered orally for 4 weeks
Active Comparator: Glim --> lira Drug: liraglutide
1.8 mg/day injected subcutaneously for 4 weeks
Drug: glimepiride
Dose individually adjusted, administered orally for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511692

Locations
Australia, South Australia
Adelaide, South Australia, Australia, 5005
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01511692     History of Changes
Other Study ID Numbers: NN2211-1589, 2006-000377-30
Study First Received: January 12, 2012
Last Updated: August 30, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014