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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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508923

Locations
Denmark
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013