To confirm superiority of liraglutide compared to placebo, both adjunct to insulin treatment, on glycaemic control, after 26 weeks of treatment in subjects with established type 1 diabetes in inadequate glycaemic control.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of
treatment.
Secondary outcome
Change from baseline in body weight after 26 weeks of treatment
Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks
of treatment
Background summary
Despite the knowledge of the benefits of improved glycaemic control, many
patients with type 1 diabetes find it a challenge to reach glycaemic targets,
not the least due to the associated potential increased risk of experiencing
hypoglycaemic episodes and weight gain.
Small scale studies and case reports in subjects with type 1 diabetes indicate
that treatment with a GLP-1 receptor agonist, such as liraglutide as adjunct to
insulin, may result in:
a) improvement in glycaemic control through reduction in fasting and
postprandial hyperglycaemia, in part due to inhibition of postprandial
hyperglucagonaemia,
b) reduction in glucose excursions,
c) reduction in episodes of hypoglycaemia,
d) reduction in insulin requirements and
e) a body weight benefit
The clinical circumstances of insulin treatment not being optimal imply, that
new efforts to improve treatment for type 1 diabetes subjects are needed.
Study objective
To confirm superiority of liraglutide compared to placebo, both adjunct to
insulin treatment, on glycaemic control, after 26 weeks of treatment in
subjects with established type 1 diabetes in inadequate glycaemic control.
Study design
The trial is a randomised, placebo-controlled, double-blinded, parallel group,
multinational, multi-centre insulin capped trial designed for evaluation of the
efficacy and safety of adding liraglutide (0.6 mg, 1.2 mg or 1.8 mg) versus
placebo to insulin treatment in subjects with type 1 diabetes during 26 weeks
of treatment. After a maximum of 2 weeks of screening, subjects will be
randomised in a 3:3:3:1:1:1 manner to liraglutide treatment (0.6 mg, 1.2 mg or
1.8 mg), or corresponding volume of liraglutide placebo both adjunct to insulin
treatment.
Intervention
Self-injection once daily with liraglutide or placebo 0.6 mg, 1.2 mg or 1.8 mg.
Study burden and risks
Subjects are requested to visit the trial site and attend telephone calls more
often than during regular treatment and several assessments are part of
standard diabetes care, but the frequency in the trial is higher. Hypoglycamia
and adverse events could occur. Therefore the subject is closely followed at
start of treatment and at dose increase, in order to adjust the insulin dose to
the subjects individual needs. Subjects will be informed of the characteristic
symptoms of acute pancreatitis and lipase, amylase and calcitonine will be
monitored closely during the trial. Subjects are requested explicitly to take
in plenty of fluids due to risk of gastrointestinal adverse events.
Liraglutide is registered for the use in diabetes type 2 and trial subjects may
have therapeutic benefits.
Flemingweg 18
Alphen aan den Rijn 2408 AV
NL
Flemingweg 18
Alphen aan den Rijn 2408 AV
NL
Listed location countries
Age
Inclusion criteria
-Informed consent obtained
-Male or female, aged *18 years
-Type 1 diabetes mellitus* 12 months
-Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment * 6 months
- Stable insulin treatment for the last 3 month prior to Screening, as judged and documented by the investigator
- HbA1c 7.0-10% (53-86 mmol/mol) both inclusive
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 >160 mmHg for systolic or >100 mmHg for diastolic
- History of acute or chronic pancreatitis
- Screening calcitonin value * 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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-005778-74-NL |
| CCMO | NL47705.060.14 |