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Completed

NCT Number: NCT01508923

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

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.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

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 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

Treatment and study plan

liraglutide

Drug

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Other names: NNC 90-1170

Placebo

Drug

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Primary outcomes

  1. 24-hour glucose profiles after three fixed meals

Secondary outcomes

  1. 24-hour insulin profiles after three fixed meals

  2. First phase insulin and maximal insulin secretory capacity

  3. EGR (endogenous glucose release) expressed in mg/kg/min

  4. GNG (gluconeogenesis) expressed in mg/kg/min

  5. 24-hour glucagon profiles after three fixed meals

  6. 24-hour FFA (free fatty acids) profiles after three fixed meals

  7. 4-hour paracetamol profiles after two fixed meals

  8. 30-hour NNC 90-1170 profile

  9. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jan 12, 2012
Registry last updated
Jan 24, 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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