The study will look at the efficacy and safety of NNC0268-0965 (referred to as insulin 965). The study aims to show that insulin 965 has positive effects on the blood vessels. Participants will get either the new insulin 965 or insulin glargine - a medicine that doctors already can prescribe (Lantus®). Which treatment participants get is decided by chance. Participants will self-administer 2 injections per day under the skin of the thighs for 26 weeks. Study participation will last for about 32 weeks. Participants will have 15 clinic visits, 2 magnetic resonance imaging (MRI) visits and 14 phone calls with the study doctor. There will be a number of in-house assessments to study the effect of the new insulin. The assessments will be explained later in detail. The treatment of disease is not an aim of this study. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are not able to become pregnant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
For subcutaneous (s.c., under the skin) injection once daily for 26 weeks
For s.c. injection once daily for 26 weeks
For s.c. injection once daily for 26 weeks
For s.c. injection once daily for 26 weeks
Profil GmbH & Co. KG
Mainz, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Change in flow mediated dilation
Percent
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Change in pulse wave velocity
m/s
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Change in leg blood flow
ml/100 ml/min
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Change in retinal arteriolar dilation
Percent
Time frame: From Visit 3A (week 0) to visit 30A (week
Relative change in liver fat percentage measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Ratio
Time frame: From Visit 2 (week 0) to visit 29 (week 26)
Change in left ventricular ejection fraction
Percent
Time frame: From Visit 2 (week 0) to visit 29 (week 26)
Change in glycosylated haemoglobin (HbA1c )
Percent
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Change in body weight
kg
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Change in body fat mass as measured by BOD POD (a method for determining the lean body mass)
Percent
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Relative change in rate of glucose disposal at short Insulin Tolerance Test
Ratio
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of adverse events
Number of events
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
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)
Number of episodes
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of clinically significant hypoglycaemic episodes s (level 2) ((below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of episodes
Time frame: From Visit 3B (week 0) to visit 30B (week 26)
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