CTRI/2024/10/074905Active, not recruitingPhase 2
Investigation of the safety and efficacy of once weekly NNC0519-0130 in participants with type 2 diabetes – a dose finding study
Novo Nordisk India Pvt Ltd8 sites in 1 country418 target enrollmentStarted: October 21, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 418
- Locations
- 8
- Primary Endpoint
- Change in HbA1c
Study Overview
Brief Summary
This is an interventional, 36-week, multi-national, multi-centre, randomised, 11-armed, dosefinding,
phase 2 study. The study will be double-blinded within dose level of once weekly (QW)
subcutaneously (s.c.) administered NNC0519-0130 and the corresponding volume-matched placebo
arms. The active comparator arm with tirzepatide will be open label
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Female of non-childbearing potential, or male.
- •2.Age 18-75 years (both inclusive) at the time of signing the informed consent.
- •3.Diagnosed with type 2 diabetes mellitus more than or equal to 180 days before screening.
- •4.Stable daily dose(s) more than or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
- •5.HbA1c of 7.5-10.0 percent (58-86 mmol per mol) (both inclusive) as assessed by central laboratory at screening.
- •6.BMI more than or equal to 23.0 kg per m2.
Exclusion Criteria
- •1.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.
- •2.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Verified by a fundus examination performed within 90 days before 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.
- •3.Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: From baseline (week 0) to | 12 weeks on a given | maintenance dose
Secondary Outcomes
- Change in body weight(From baseline (week 0) to)
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to)
- Continuous glucose(monitoring (CGM))
- Number of adverse(events)
Investigators
Study Sites (8)
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