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

Novo Nordisk logo

Novo Nordisk

Status and phase

Completed
Phase 2

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: placebo
Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01508923
NN2211-1332

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

17 participants in 2 patient groups, including a placebo group

Treatment period 1
Experimental group
Treatment:
Drug: placebo
Drug: liraglutide
Treatment period 2
Placebo Comparator group
Treatment:
Drug: placebo
Drug: liraglutide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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