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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014