To compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve 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 from baseline to week 30 in HbA1c.
Secondary outcome
Change from baseline to week 30 in:
* body weight
* Fasting plasma glucose (FPG)
* Systolic and diastolic blood pressure
* Patient reported outcome questionnaires (PROs)
Subjects who after 30 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 once-weekly dosing of two dose levels of semaglutide
versus insulin glargine once-daily on glycaemic control after 30 weeks of
treatment in insulin-naïve subjects with type 2 diabetes.
Study design
This is a 30-week randomised, open-label, active-controlled, parallel-group,
multicentre, multi-national, three-armed trial comparing two doses of
semaglutide (0,5 mg and 1,0 mg) once-weekly versus insulin glargine once-daily.
Insulin-naïve subjects with type 2 diabetes inadequately controlled with
metformin or metformin and sulphonylurea (SU) will after a 2 weeks screening
period be randomised in a 1:1:1 manner to receive either a dose of 0.5 mg or
1.0 mg of semaglutide once weekly or insulin glargine once daily treated to
target (T-T-T).
The treatment period is 30 weeks in total and is followed by a follow-up visit
after 5 weeks. Total trial duration for the individual subjects will be up to
37 weeks.
Intervention
Self-injection of semaglutide 0,5 mg or 1.0 mg once-weekly or insuline glargine
once-daily.
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 the potential risks. The safety profile of semaglutide generated from
the clinical and non-clinical development programme has not revealed any safety
issues that would prohibit administration of once weekly doses of 0.5 mg or 1.0
mg semaglutide in accordance with the planned clinical trial. 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 people with type 2
diabetes.
IGlar is approved for treatment of type 2 diabetes in several countries
including US and EU and it is concluded that the risk to the subjects treated
with IGlar in this trial is low.
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Listed location countries
Age
Inclusion criteria
1. Male or female, age *18 years at the time of signing informed consent;2. Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin *1500 mg or maximum tolerated dose and SU * half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose;3. HbA1c 7.0 * 10.0% (53 - 86 mmol/mol) both inclusive
Exclusion criteria
1. Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period;2. Any disorder which, in the opinion of the Investigator might jeopardise subject*s safety or compliance with the protocol;3. Treatment with any 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 intercurrent illness;4. History of chronic or idiopathic acute pancreatitis;5. Screening calcitonin value *50 ng/L;6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2;7. Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version);8. Acute coronary or cerebrovascular event within 90 days before randomisation;9. Heart failure, New York Heart Association Class IV;10. Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator;11. 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 | EUCTR2013-004392-12-NL |
| ClinicalTrials.gov | NCT02128932 |
| CCMO | NL47781.018.14 |