Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies. Participants will either get: Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine). NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance. Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo. Participant must inject the study medicines themself into the stomach, thigh, or upper arm. The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study. Women can only take part in the study if they are not able to become pregnant
Interventions
DRUGNNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
DRUGSemaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
DRUGPlacebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
DRUGPlacebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose * HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) * BMI greater than or equal to 25 and below 40 kg/m\^2
Exclusion criteria
* 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 days and prior insulin treatment for gestational diabetes are allowed * 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 * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Change From Baseline in Body Weight (Kilogram [kg]) | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Percent Change From Baseline in Body Weight | Baseline (week 0), (week 34) | Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Change From Baseline in Waist Circumference | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Change From Baseline in Systolic Blood Pressure (SBP) | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in Total Cholesterol - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in Triglycerides - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline | Baseline (week 0), (week 34) | Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | Baseline (week 0), (week 34) | Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication. |
| Number of Treatment-Emergent Adverse Events (TEAEs) | Baseline (week 0) to (week 39) | An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment. |
Countries
Bulgaria, Denmark, Greece, Hungary, Japan, Poland, Russia, Serbia, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 1452)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted in 9 countries (86 sites screened/83 randomised participants) as follows: Bulgaria: 6/6; Denmark: 3/3; Greece: 7/7; Hungary: 9/9; Japan: 6/6; Poland: 10/10; Russia: 4/4; Serbia: 3/3; United States of America (USA): 38/35. In addition, Hungary (1 site), Poland (1 site), Serbia (1 site) and USA (5 site) were approved by the institutional review board, but did not screen any participants.
Pre-assignment details
The trial had a 34-week intervention period (10 weeks of dose escalation period and followed by two 12 -week maintenance period), followed by a 5-week follow-up period.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59 Years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 11 Participants |
| Race/Ethnicity, Customized Race Black or African American | 17 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants |
| Race/Ethnicity, Customized Race White | 53 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 74 | 0 / 77 | 0 / 77 | 0 / 75 | 0 / 59 | 0 / 61 |
| other Total, other adverse events | 40 / 77 | 44 / 74 | 36 / 77 | 37 / 77 | 34 / 75 | 25 / 59 | 23 / 61 |
| serious Total, serious adverse events | 6 / 77 | 3 / 74 | 2 / 77 | 5 / 77 | 3 / 75 | 2 / 59 | 2 / 61 |
Outcome results
None listed