Type 2 Diabetes, Obesity
Conditions
Brief summary
Due to reports of a severely reduced insulinotropic effect of the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) in type 2 diabetes (T2D), GIP has not been considered therapeutically viable in T2D. Recently, however, tirzepatide, a novel dual incretin receptor agonist (activating both the GIP receptor and the glucagon-like peptide 1 (GLP-1) receptor) demonstrated massive improvements in glycaemic control and robust body weight losses; greater than observed with the GLP-1 receptor agonist semaglutide. However, the contribution of GIP receptor activation to these effects remains unknown. The present study will evaluate the glucose-lowering effect of GIP in the context of pharmacological GLP-1 receptor activation in patients with T2D.
Interventions
DRUGSemaglutide 1.34 MG/ML [Ozempic]
Semaglutide 1.34 mg/ml
OTHERSemaglutide 1.34 mg/ml placebo
Saline
OTHERGIP placebo
Saline
Sponsors
Asger Lund, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2. Men and women 18 to 74 years of age (both inclusive) at the time of signing informed consent 3. Diagnosed with type 2 diabetes for at least six months 1. Treated with diet and exercise and/or stable metformin and/or sodium-glucose cotransporter 2 (SGLT-2) inhibitor and/or dipeptidyl-peptidase 4 inhibitor (DPP-4i) and/or sulfonylureas (SU) treatment for at least 3 months If treated with DPP-4i and/or SU, this treatment must be paused for 14 days prior to first CGM period in the trial 2. HbA1c ≥48 to ≤91 mmol/mol 4. BMI ≥25 to ≤50 kg/m2 5. Stable body weight (less than 3 kg self-reported change during the previous 90 days)
Exclusion criteria
For an eligible participant, all
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose levels (assessed by blinded continuous glucose monitoring (CGM)) | 14-day mean glucose levels during the last 14 days of the intervention period as compared to 14-day mean glucose levels during the last 14 days of the run-in period. | The primary outcome is change in 14-day mean glucose levels (assessed by CGM) during the last 14 days of the intervention period as compared to 14-day mean glucose levels during the last 14 days of the run-in period. |
Countries
Denmark
Outcome results
None listed