Diabetes Mellitus, Overweight, Obesity
Conditions
Brief summary
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Interventions
DRUGNNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening. * Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening. * Haemoglobin A1c (HbA1c) 7-10% \[53-86 (millimoles per mole) mmol/mol\] (both inclusive) as measured by the central laboratory at screening.
Exclusion criteria
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 m\^2) \[2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\], at screening. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye 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. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to (week 84) | Measured as percentage (%) of body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | From baseline (week 0) to (week 84) | Measured as centimetre (cm). |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to (week 84) | Measured as percentage (%) of HbA1c. |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to (week 84) | Measured as millimetre of mercury (mmHg). |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score | From baseline (week 0) to (week 84) | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning. |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | From baseline (week 0) to (week 84) | Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. The physical functioning ranges from 19.0 to 57.6. Higher scores indicate better functional health and well-being. |
| Change in body weight | From baseline (week 0) to (week 84) | Measured as kilogram (kg). |
| Change in body mass index (BMI) | From baseline (week 0) to (week 84) | Measured as kilograms per meter squared (kg/m\^2). |
| Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score | From baseline (week 0) to (week 84) | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning. |
| Achievement of HbA1c < 7.0% (Yes/No) | From baseline (week 0) to (week 84) | Measured as number of participants |
| Achievement of HbA1c ≤ 6.5% (Yes/No) | From baseline (week 0) to (week 84) | Measured as number of participants |
| Achievement of HbA1c < 5.7% (Yes/No) | From baseline (week 0) to (week 84) | Measured as number of participants |
| Change in fasting plasma glucose (FPG) (mmol/L) | From baseline (week 0) to (week 84) | Measured as millimoles per liter (mmol/L) |
| Change in fasting plasma glucose (FPG) (mg/dL) | From baseline (week 0) to (week 84) | Measured as milligram per deciliter (mg/dL) |
| Change in fasting insulin | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in urinary albumin-to-creatinine ratio (UACR) | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in diastolic blood pressure | From baseline (week 0) to (week 84) | Measured as mmHg. |
| Change in high-sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to week 88 | Measured as count of events. |
| Number of Treatment Emergent Serious Adverse Events (TESAEs) | From baseline (week 0) to week 88 | Measured as count of events. |
| Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation | From baseline (week 0) to week 88 | Measured as count of events. |
| Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter) | From baseline (week 0) to week 88 | Measured as number of episodes |
| Number of treatment emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | From baseline (week 0) to week 88 | Measured as number of episodes |
| Change in Total cholesterol | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in High-density lipoprotein (HDL) cholesterol | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in Low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in Very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in Non-HDL cholesterol | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
| Change in Triglycerides | From baseline (week 0) to (week 84) | Measured as ratio to baseline. |
Countries
Argentina, Brazil, Croatia, Hungary, Italy, Mexico, Romania, Slovakia, South Korea, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed