To confirm superiority on glycaemic control of liraglutide versus placebo after 26 weeks of treatment when added to pre-existing basal insulin analogue treatment (with or without concomitant metformin treatment) in subjects with type 2 diabetes.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in HbA1c from baseline to week 26.
Secondary outcome
Change from baseline to week 26 in:
• Fasting plasma glucose (FPG).
• 7-point self-measured plasma glucose
• Body weight
After 26 weeks treatment:
Number of subjects achieving:
• HbA1c < 7.0% (American Diabetes Association (ADA) target).
• HbA1c <= 6.5% (American Association of Clinical Endocrinologists (AACE)
target)
Safety (after 26 weeks of treatment)
Number of subjects with:
• Adverse events (AEs)
• Minor or severe hypoglycaemic episodes
Background summary
The progressive nature of type 2 diabetes combined with its increasing
prevalence and the fact that patients are being diagnosed at a progressively
younger age, mean that an increasing number of patients require insulin
therapy to maintain glycaemic control.
Liraglutide has proven to be a well-tolerated and efficacious treatment option
in a wide variety of subjects with type 2 diabetes when added to OADs.
Treatment with liraglutide leads to substantial and clinically relevant
lowering of HbA1c and reductions in body weight without increased risk of
hypoglycaemic episodes due to the glucose dependent mode-of-action. These
effects indicate that liraglutide may be a valuable complementary treatment
option in type 2 diabetic patients insufficiently controlled on insulin therapy.
Currently, liraglutide is not approved for use in combination with insulin.
However, results from a recent phase 3b trial have shown that intensification
of treatment with insulin detemir in subjects with type 2 diabetes not
achieving adequate glycaemic control with liraglutide + metformin was
well-tolerated and efficacious.
Studies indicate that addition of a GLP-1 receptor agonist to pre-existing
insulin therapy can favourably affect the daily glucose variability by reducing
plasma glucose excursions and provide improved glycaemic control with
significant reductions in HbA1c. These effects of the combination therapy
seemed associated with a reduced need for insulin, weight loss and no
substantial increase in the risk of hypoglycaemic events. The efficacy and
safety of liraglutide as add on to basal insulin analogues has however, never
been established in a controlled, double blind setting.
Study objective
To confirm superiority on glycaemic control of liraglutide versus placebo after
26 weeks of treatment when added to pre-existing basal insulin analogue
treatment (with or without concomitant metformin treatment) in subjects with
type 2 diabetes.
Study design
The trial is a 26 week, randomised, double-blind, placebo-controlled two-armed,
parallel group, multi-centre, multi-national trial.
Subjects will be randomised in a 1:1 manner to receive a once daily dose of
liraglutide 1.8 mg or liraglutide placebo.
Intervention
Participants will inject themselves with Liraglutide, 6.0 mg/mL or liraglutide
placebo
Study burden and risks
Patients will have to visit the clinic more often for the trial. They will get
more venapunctures and will be asked to perform home blood glucose
measurements. Liraglutide is already a marketed product. Patient could
experience side effects from using liraglutide.
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Listed location countries
Age
Inclusion criteria
-Diagnosed with type 2 diabetes for at least 180 days prior to screening
-HbA1c 7.0-10.0% (both inclusive)
-Body mass index (BMI) 20.0-45.0 kg/m2 (both inclusive)
-Age 18-80 years (both inclusive)
Exclusion criteria
•Female who is pregnant, breast-feeding or intend to become pregnant
•Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
•Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
•Impaired liver or renal function
•Uncontrolled treated or untreated hypertension (SBP >=180 mmHg and/or DBP >=100 mmHg)
•Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator*s opinion could interfere with results of the trial
•Known or suspected abuse of alcohol or narcotics
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 | EUCTR2011-002696-41-NL |
| CCMO | NL40373.075.12 |