The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

Diabetes Clinical Trial

— ADJUNCT TWO™  

Official title:

A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098395
• Other study ID #: NN9211-4083
• Secondary ID: 2012-005778-74U1
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2014
• Last updated: April 27, 2015
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaSouth Africa: Medicines Control CouncilAustria: Agency for Health and Food SafetyBulgaria: Bulgarian Drug AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Ministry of HealthNetherlands: Dutch Health Care InspectorateItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

• Male or female, aged equal to or greater than 18 years at the time of signing informed consent

• Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)

• Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)

• Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator

• HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion Criteria:

• Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors

• Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed

• Known proliferative retinopathy or maculopathy requiring acute treatment

• Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator

• Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)

• History of acute or chronic pancreatitis

• Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• liraglutide
Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
• liraglutide
Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
• liraglutide
Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will remain on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
• placebo
Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
• placebo
Subjects randomised to 0.2 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
• placebo
Subjects randomised to 0.1 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Albany	New York
United States	Novo Nordisk Clinical Trial Call Center	Amarillo	Texas
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Aurora	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Austin	Texas
United States	Novo Nordisk Clinical Trial Call Center	Austin	Texas
United States	Novo Nordisk Clinical Trial Call Center	Bennington	Vermont
United States	Novo Nordisk Clinical Trial Call Center	Billings	Montana
United States	Novo Nordisk Clinical Trial Call Center	Bristol	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Butte	Montana
United States	Novo Nordisk Clinical Trial Call Center	Champaign	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Chapel Hill	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Chesterfield	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Chicago	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Chino	California
United States	Novo Nordisk Clinical Trial Call Center	Concord	California
United States	Novo Nordisk Clinical Trial Call Center	Council Bluffs	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Escondido	California
United States	Novo Nordisk Clinical Trial Call Center	Fargo	North Dakota
United States	Novo Nordisk Clinical Trial Call Center	Federal Way	Washington
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Golden	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Jamaica	New York
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Little Rock	Arkansas
United States	Novo Nordisk Clinical Trial Call Center	Maitland	Florida
United States	Novo Nordisk Clinical Trial Call Center	Marietta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota
United States	Novo Nordisk Clinical Trial Call Center	Morehead City	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Murray	Utah
United States	Novo Nordisk Clinical Trial Call Center	Ogden	Utah
United States	Novo Nordisk Clinical Trial Call Center	Phoenix	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Renton	Washington
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Roswell	Georgia
United States	Novo Nordisk Clinical Trial Call Center	San Mateo	California
United States	Novo Nordisk Clinical Trial Call Center	San Ramon	California
United States	Novo Nordisk Clinical Trial Call Center	Seattle	Washington
United States	Novo Nordisk Clinical Trial Call Center	Skokie	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Staten Island	New York
United States	Novo Nordisk Clinical Trial Call Center	Ventura	California
United States	Novo Nordisk Clinical Trial Call Center	Walnut Creek	California
United States	Novo Nordisk Clinical Trial Call Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Canada,  Denmark,  Finland,  France,  Italy,  Netherlands,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycosylated haemoglobin (HbA1c)		Week 0, Week 26	No
Secondary	Change from baseline in body weight		Week 0, Week 26	No
Secondary	Number of treatment-emergent symptomatic hypoglycaemic episodes		Weeks 0-26	No

External Links

•   Clinical Trials at Novo Nordisk