Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01508923
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NNC 90-1170
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of NNC 90-1170 on 24-hour Glucose and Hormonal Profiles, Gastric Emptying, and Fasting Gluconeogenesis in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, Cross-over Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 24-hour glucose profiles after three fixed meals [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24-hour insulin profiles after three fixed meals [ Designated as safety issue: No ]
  • First phase insulin and maximal insulin secretory capacity [ Designated as safety issue: No ]
  • EGR (endogenous glucose release) expressed in mg/kg/min [ Designated as safety issue: No ]
  • GNG (gluconeogenesis) expressed in mg/kg/min [ Designated as safety issue: No ]
  • 24-hour glucagon profiles after three fixed meals [ Designated as safety issue: No ]
  • 24-hour FFA (free fatty acids) profiles after three fixed meals [ Designated as safety issue: No ]
  • 4-hour paracetamol profiles after two fixed meals [ Designated as safety issue: No ]
  • 30-hour NNC 90-1170 profile [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2001
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1 Drug: NNC 90-1170
6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
Drug: placebo
6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
Placebo Comparator: Treatment period 2 Drug: NNC 90-1170
6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
Drug: placebo
6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included
  • Body Mass Index (BMI) maximum 35 kg/m^2
  • Fasting plasma glucose 7-15 mmol/l, both inclusive

Exclusion Criteria:

  • Impaired liver function
  • Impaired renal function
  • Anaemia
  • Cardiac disease
  • Uncontrolled treated/untreated hypertension
  • Recurrent major hypoglycaemia as judged by the Investigator
  • Known or suspected allergy to trial product or related products
  • Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
  • Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
  • Loss of more than 400 ml blood during the three months prior to study start
  • Allergy to paracetamol
  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: NCT01508923

Locations
Denmark
Århus C, Denmark, 8000
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: NCT01508923     History of Changes
Other Study ID Numbers: NN2211-1332
Study First Received: January 9, 2012
Last Updated: January 9, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014