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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507311
First received: January 6, 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 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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NNC 90-1170
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin secretory burst mass [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin secretory pulse mass, amplitude, frequency and regularity [ Designated as safety issue: No ]
  • Insulin secretion [ Designated as safety issue: No ]
  • Glucagon response [ Designated as safety issue: No ]
  • Gastric emptying rate [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: September 1999
Study Completion Date: December 1999
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: NNC 90-1170
A single dose injected subcutaneously (under the skin)
Placebo Comparator: Placebo Drug: placebo
A single dose injected subcutaneously (under the skin)

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 OHAs) which in the investigator's opinion could interfere
  • with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
  • Liver or renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507311

Locations
Denmark
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter Damsbo, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507311     History of Changes
Other Study ID Numbers: NN2211-1219
Study First Received: January 6, 2012
Last Updated: January 6, 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 April 17, 2014