To compare the effect of semaglutide 1.0 mg once-weekly versus exenatide extended release (ER) 2.0 mg once-weekly on glycaemic control after 56 weeks of treatment.
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 to week 56 in HbA1c.
Secondary outcome
*Change from baseline to week 56 in body weight
*Change from baseline to week 56 in: Fasting Plasma Glucose (FPG), Systolic and
diastolic blood pressure, Patient reported outcome (PRO) questionnaire Diabetes
Treatment Satisfaction Questionnaire status (DTSQs)
*Subjects who after 56 weeks treatment achieve (yes/no): HbA1c *6.5% (48
mmol/mol) American Association of Clinical Endocrinologists (AACE) target
Background summary
The currently available treatment modalities for type 2 diabetes are still not
satisfactory and there is a large proportion of patients not reaching the
treatment targets despite high level of compliance with the treatment regimens.
Furthermore, there is a segment of patients where either compliance with
once-daily treatment regimens is an issue resulting in sub-optimal glycaemic
control, or where there is a wish for a more convenient treatment regimen.
Therefore, development of once-weekly GLP-1 analogues have the potential to
fulfil a medical need.
Study objective
To compare the effect of semaglutide 1.0 mg once-weekly versus exenatide
extended release (ER) 2.0 mg once-weekly on glycaemic control after 56 weeks of
treatment.
Study design
This is a 56-weeks randomised, open-label, active-controlled parallel-group,
multi-national, multicentre trial. Subjects will be randomised in a 1:1 manner
to receive a dose of 1.0 mg semaglutide once-weekly or exenatide ER 2.0 mg
once-weekly. Trial product will be add-on to the subject*s pre-trial medication
consisting of 1-2 of the following compounds: metformin, sulfonylureas (SU) or
thiazolidinediones (TZDs).
Intervention
Self-injection of semaglutide 1.0 mg once-weekly or exenatide ER 2.0 mg
once-weekly.
Study burden and risks
Subjects will have to visit the clinic more often for the trial. They will get
more venapunctures and will be asked to perform blood glucose measurements.
There is also a risk of side effects. It is concluded that the potential
benefits from participating in the trial outweigh these potential risks. The
safety profile of semaglutide generated from the clinical and nonclinical
development programme has not revealed any safety issues that would prohibit
administration of once weekly doses of 1.0 mg semaglutide in accordance with
the planned clinical trial. Exenatide ER is already a marketed drug in the 2 mg
dose and approved for the use in type 2 diabetic patients. It is concluded that
the risk to the subjects in this trial is low and acceptable in view of the
benefits a long-acting GLP-1 analogue would provide to subjects with type 2
diabetes.
Flemingweg 18
Alphen aan den Rijn 2408 AV
NL
Flemingweg 18
Alphen aan den Rijn 2408 AV
NL
Listed location countries
Age
Inclusion criteria
*Male or female, age * 18 years at the time of signing informed consent.
*Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin * 1500 mg or maximum tolerated dose and/or TZD and/or SUs * half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose
*HbA1c 7.0 * 10.5 % (53 * 91 mmol/mol) (both inclusive)
Exclusion criteria
*Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice)
*Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject*s safety or compliance with the protocol
*Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (* 7 days in total) with insulin in connection with inter-current illness
*History of chronic or idiopathic acute pancreatitis
*Screening calcitonin value * 50 ng/L (pg/mL)
*Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
*Impaired renal function defined as eGFR < 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version)
*Acute coronary or cerebrovascular event within 90 days before randomisation
*Heart failure, New York Heart Association (NYHA) class IV
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | EUCTR2012-004826-92-NL |
| CCMO | NL44815.098.13 |