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NCT01836523 Clinical Trial

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

Diabetes Clinical Trial

— ADJUNCT ONE™  

Official title:
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01836523
Other study ID # NN9211-3919
Secondary ID 2012-003580-21U1
Status Completed
Phase Phase 3
First received April 17, 2013
Last updated June 9, 2015
Start date November 2013
Est. completion date June 2015

Study information
Verified date June 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationPoland: Ministry of HealthNorway: Norwegian Medicines AgencyIreland: Irish Medicines BoardFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesNetherlands: Dutch Health Care InspectorateUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFinland: Finnish Medicines AgencySweden: Medical Products AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaIsrael: Ministry of HealthRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
Study type Interventional

Clinical Trial Summary

This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 1398
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Informed consent obtained

- Type 1 diabetes mellitus for 12 months or longer

- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer

- Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator

- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))

- Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits

Exclusion Criteria:

- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors

- Use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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 above 160 mmHg for systolic or above 100 mmHg for diastolic

- History of acute or chronic pancreatitis

- Screening calcitonin value equal to or above 50 ng/L

- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)

- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

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

Intervention

Drug:
• liraglutide
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
• placebo
Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
• liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 2 weeks followed by 1.2 mg for 50 weeks as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily.
• placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 2 weeks followed by 1.2 mg for 50 weeks as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily.
• liraglutide
Subjects randomised to 1.8 mg liraglutide treatment or liraglutide placebo will receive, in addition to their pre-trial insulin treatment, 0.6 mg for 2 weeks followed by 1.2 mg for 2 weeks. After 4 weeks of liraglutide treatment or liraglutide placebo, subjects will receive 1.8 mg for 48 weeks. Administered subcutaneously (s.c., under the skin) once daily.
• placebo
Subjects randomised to 1.8 mg liraglutide treatment or liraglutide placebo will receive, in addition to their pre-trial insulin treatment, 0.6 mg for 2 weeks followed by 1.2 mg for 2 weeks. After 4 weeks of liraglutide treatment or liraglutide placebo, subjects will receive 1.8 mg for 48 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 Atlanta Georgia
United States Novo Nordisk Clinical Trial Call Center Austin Texas
United States Novo Nordisk Clinical Trial Call Center Baltimore Maryland
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 Butte Montana
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
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 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 Dallas Texas
United States Novo Nordisk Clinical Trial Call Center Denver Colorado
United States Novo Nordisk Clinical Trial Call Center El Paso Texas
United States Novo Nordisk Clinical Trial Call Center Encino California
United States Novo Nordisk Clinical Trial Call Center Escondido California
United States Novo Nordisk Clinical Trial Call Center Federal Way Washington
United States Novo Nordisk Clinical Trial Call Center Greensboro North Carolina
United States Novo Nordisk Clinical Trial Call Center Greer South Carolina
United States Novo Nordisk Clinical Trial Call Center Hialeah Florida
United States Novo Nordisk Clinical Trial Call Center Hollywood Florida
United States Novo Nordisk Clinical Trial Call Center Huntington Beach California
United States Novo Nordisk Clinical Trial Call Center Idaho Falls Idaho
United States Novo Nordisk Clinical Trial Call Center Indianapolis Indiana
United States Novo Nordisk Clinical Trial Call Center Iowa City Iowa
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center La Mesa California
United States Novo Nordisk Clinical Trial Call Center Lancaster California
United States Novo Nordisk Clinical Trial Call Center Lawrenceville New Jersey
United States Novo Nordisk Clinical Trial Call Center Little Rock Arkansas
United States Novo Nordisk Clinical Trial Call Center Marietta Georgia
United States Novo Nordisk Clinical Trial Call Center Memphis Tennessee
United States Novo Nordisk Clinical Trial Call Center Mentor Ohio
United States Novo Nordisk Clinical Trial Call Center Metarie Louisiana
United States Novo Nordisk Clinical Trial Call Center Milwaukee Wisconsin
United States Novo Nordisk Clinical Trial Call Center Mineola New York
United States Novo Nordisk Clinical Trial Call Center Minneapolis Minnesota
United States Novo Nordisk Clinical Trial Call Center Monterey California
United States Novo Nordisk Clinical Trial Call Center Morehead City North Carolina
United States Novo Nordisk Clinical Trial Call Center Myrtle Beach South Carolina
United States Novo Nordisk Clinical Trial Call Center Nashville Tennessee
United States Novo Nordisk Clinical Trial Call Center Nashville Tennessee
United States Novo Nordisk Clinical Trial Call Center New York New York
United States Novo Nordisk Clinical Trial Call Center New York New York
United States Novo Nordisk Clinical Trial Call Center Norfolk Virginia
United States Novo Nordisk Clinical Trial Call Center Pittsburgh Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Roswell Georgia
United States Novo Nordisk Clinical Trial Call Center Round Rock Texas
United States Novo Nordisk Clinical Trial Call Center Salt Lake City Utah
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 Savannah Georgia
United States Novo Nordisk Clinical Trial Call Center Spokane Washington
United States Novo Nordisk Clinical Trial Call Center Springfield Missouri
United States Novo Nordisk Clinical Trial Call Center St. Charles Missouri
United States Novo Nordisk Clinical Trial Call Center St. Louis Missouri
United States Novo Nordisk Clinical Trial Call Center St. Peters Missouri
United States Novo Nordisk Clinical Trial Call Center Staten Island New York
United States Novo Nordisk Clinical Trial Call Center Sugarland Texas
United States Novo Nordisk Clinical Trial Call Center Summerville South Carolina
United States Novo Nordisk Clinical Trial Call Center Syracuse New York
United States Novo Nordisk Clinical Trial Call Center Tampa Florida
United States Novo Nordisk Clinical Trial Call Center Topeka Kansas
United States Novo Nordisk Clinical Trial Call Center Upper Darby Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Finland,  France,  Germany,  Ireland,  Israel,  Netherlands,  Norway,  Poland,  Russian Federation,  Sweden,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c (glycosylated haemoglobin) Week 0, week 52 No
Primary Change from baseline in body weight Week 0, week 52 No
Primary Change from baseline in total daily insulin dose Week 0, week 52 No
Secondary Number of treatment-emergent symptomatic hypoglycaemic episodes. Weeks 0-52 No
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