Diabetes Clinical Trial
— ADJUNCT TWO™Official title:
A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Austria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Italy, Netherlands, South Africa, Spain, Sweden,
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 |
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