A research study in people with type 2 diabetes to compare two types of insulin: insulin 287 and insulin glargine
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2018-003407-18-IT
- Lead Sponsor
- OVO NORDISK. S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 154
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus = 180 days prior to the day of screening.
4. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
5. Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) = 90 days prior to the day of screening.
6. 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):
Any metformin formulations = 1500 mg or maximum tolerated or effective dose (as documented in subjects medical records)
Any metformin formulations = 1500 mg or maximum tolerated or effective dose with DPP4i = half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subjects medical records)
7. Body mass index (BMI) = 40.0 kg/m2
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. For Czech Republic and Germany, please see country specific requirements in Appendix 10.
4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
5. Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
6. Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
7. Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question 8.1
8. Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
9. 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.
10. Presently classified as being in New York Heart Association (NYHA) Class IV.
11. Planned coronary, carotid or peripheral artery revascularisation, between screening and randomisation.
12. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR <60 ml/min/1.73 m2 as defined by KDIGO 2012.13
13. Impaired liver function, defined as Alanine Aminotransferase (ALT) = 2.5 times or Bilirubin >1.5 times upper normal limit at screening
14. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic =180 mmHg or diastolic =110 mmHg) at screening.
15. 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.
16. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
17. Presence or history of malignant neoplasms within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect on glycaemic control of treatment with once weekly insulin 287 using 2 different switch approaches versus once daily insulin glargine U100 both in combination with metformin ± DPP4 inhibitors (DPP4i) in basal insulin analogue treated T2DM subjects.;Secondary Objective: To compare the safety and tolerability of once weekly insulin 287 using 2 different switch approaches versus once daily insulin glargine U100 both in combination with metformin ± DPP4i in basal insulin analogue treated T2DM subjects.;Primary end point(s): Time in target range 3.9–10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM);Timepoint(s) of evaluation of this end point: Last 2 weeks of treatment (week 15 and 16)
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1-3.From baseline week 0 (V2) to week 16 (V18)<br>4. During the last 2 weeks of treatment (week 15 and 16)<br>5. From baseline week 0 (V2) to week 21 (V20)<br>6 -8 From baseline week 0 (V2) to week 16 (V18);Secondary end point(s): 1. Change in HbA1c<br>2. Change in fasting plasma glucose (FPG)<br>3. Change in body weight<br>4. Weekly insulin dose<br>5. Number of treatment emergent adverse events (TEAEs)<br>6. Number of severe hypoglycaemic episodes (level 3)<br>7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)<br>8. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter)