A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovo Nordisk A/S

About this trial

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.

Eligibility criteria

Qualifiers

Male or female (sex at birth).

Age 18-75 years (both inclusive) at the time of signing the informed consent.

Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole [mmol/mol]) (both inclusive) as assessed by central laboratory at screening.

Willingness to obtain a high weight loss (greater than [>] 25% of weight at baseline).

Disqualifiers

Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.

Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.

Trial design

Treatments tested in this trial

  • NNC0662-0419
  • Semaglutide
  • Placebo

Treatment groups

270 Participants
are divided into 3 treatment groups

Locations

63
Croatia
Opca bolnica Karlovac47000, Karlovac Croatia
Poliklinika SLAVONIJA OSIJEK31000, Osijek Croatia
Opca bolnica Varazdin_Endocrinology42 000, Varaždin Croatia
Poliklinika Solmed10000, Zagreb Croatia

Sponsors and collaborators

Novo Nordisk A/S

Lead sponsor