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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507311
First received: January 6, 2012
Last updated: January 23, 2017
Last verified: January 2017
January 6, 2012
January 23, 2017
September 1999
December 1999   (Final data collection date for primary outcome measure)
Insulin secretory burst mass
Same as current
Complete list of historical versions of study NCT01507311 on ClinicalTrials.gov Archive Site
  • Insulin secretory pulse mass, amplitude, frequency and regularity
  • Insulin secretion
  • Glucagon response
  • Gastric emptying rate
  • Adverse events
Same as current
Not Provided
Not Provided
 
Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes
Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    A single dose injected subcutaneously (under the skin)
    Other Name: NNC 90-1170
  • Drug: placebo
    A single dose injected subcutaneously (under the skin)
  • Experimental: NNC 90-1170
    Intervention: Drug: liraglutide
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Juhl CB, Hollingdal M, Sturis J, Jakobsen G, Agersø H, Veldhuis J, Pørksen N, Schmitz O. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes. 2002 Feb;51(2):424-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
December 1999
December 1999   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01507311
NN2211-1219
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP