A research study to compare insulin 287 once a week to insulin glargine (100 units/mL) once a day in people with type 2 diabetes.
- Conditions
- Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Diabetes Mellitus, Type 2MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
- Registration Number
- EUCTR2018-000322-63-SI
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
- HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory.
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
a) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical record).
b) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject medical record) with DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subject's medical records).
- Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- Body mass index (BMI) less than or equal to 40.0 kg/sqm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
- Presently classified as being in New York Heart Association (NYHA) Class IV.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect on glycaemic control after 26 weeks treatment of once weekly insulin 287<br>versus once daily insulin glargine both in combination with metformin with or without dipeptidyl<br>peptidase-4 inhibitors in insulin-naïve type 2 diabetes mellitus subjects inadequately treated with<br>metformin with or without dipeptidyl peptidase-4 inhibitors.;Secondary Objective: To investigate the safety and tolerability during 26 weeks of treatment with once weekly insulin 287<br>versus once daily insulin glargine both in combination with metformin with or without dipeptidyl<br>peptidase-4 inhibitors in insulin-naïve subjects with type 2 diabetes mellitus inadequately treated<br>with metformin with or without dipeptidyl peptidase-4 inhibitors.;Primary end point(s): Change in glycated haemoglobin (HbA1c) (%-point and<br>[mmol/mol]);Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 26
- Secondary Outcome Measures
Name Time Method