Health Trials

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

ConditionDiabetes Mellitus, Type 2
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • NNC0662-0419

    Drug

    NNC0662-0419 will be administered subcutaneously.

  • Semaglutide

    Drug

    Semaglutide will be administered subcutaneously.

  • Placebo

    Drug

    Placebo will be administered subcutaneously.

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: NNC0662-0419Experimental treatment 1 intervention
Group B: SemaglutideActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in glycated haemoglobin (HbA1c) (week 16)

Measured as percentage-point (%-point).

Time frame
From baseline (week 0) to week 16
2

Change in HbA1c (week 28)

Measured as %-point.

Time frame
From baseline (week 0) to week 28
3

Change in HbA1c (week 40)

Measured as %-point.

Time frame
From baseline (week 0) to week 40

Secondary outcomes

1

Relative change in body weight

Measured as percentage (%).

Time frame
From baseline (week 0) to (week 40)
2

Change in body weight

Measured as kilogram (kg).

Time frame
From baseline (week 0) to (week 40)
3

Change in HbA1c

Measured as %-point.

Time frame
From baseline (week 0) to (week 16, 28 and 40)
4

Change in Fasting Plasma Glucose (FPG)

Measured as millimoles per litre (mmol/L).

Time frame
From baseline (week 0) to (week 16, 28 and 40)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
Apply now