Status:
COMPLETED
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- \- 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
- \- 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)
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
1398 Patients enrolled
Trial Details
Trial ID
NCT01836523
Start Date
November 1 2013
End Date
June 1 2015
Last Update
March 6 2017
Active Locations (182)
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1
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205
2
Novo Nordisk Investigational Site
Concord, California, United States, 94520
3
Novo Nordisk Investigational Site
Encino, California, United States, 91436
4
Novo Nordisk Investigational Site
Escondido, California, United States, 92025