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Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: placebo
Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507311
NN2211-1219

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

Enrollment

11 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
  • BMI (Body Mass Index) between 24 and 35 kg/m^2 (both inclusive)
  • Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
  • Anti-GAD (glutamic acid decarboxylase) negative

Exclusion criteria

  • Known or suspected allergy to trial product or related products
  • Receipt of any investigational drug within three months prior to this trial
  • Recurrent severe hypoglycaemia as judged by the investigator
  • Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
  • Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
  • with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
  • Liver or renal disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

11 participants in 2 patient groups, including a placebo group

NNC 90-1170
Experimental group
Treatment:
Drug: liraglutide
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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