Effects of a 6-week subcutaneous infusion of native GIP alone or as add-on to semaglutide in people with type 2 diabetes: a single-centre, double-blind, parallel-group, randomised, placebo-controlled trial
Authors' conclusion
6 weeks of subcutaneous GIP infusion as add-on to placebo or semaglutide did not improve glycaemic control in individuals with type 2 diabetes at the prespecified target of 1.50 mmol/L. Due to dropouts, we cannot draw firm conclusions on the effects of GIP as add-on to placebo.
Study context
- Population
- Adults aged 18–74 years with T2D ≥6 months, stable treatment, HbA1c 6.5–10.5% (48–91 mmol/mol), BMI 25–50 kg/m²; single centre, Hellerup, Denmark10 discontinued
- Participants
- 61 adults
- Comparison
- GIP infusion vs placebo, alone or as add-on to semaglutide
- Placebo plus placebon = 15reference
- Placebo plus GIPn = 16
- Semaglutide plus placebon = 15reference
- Semaglutide plus GIPn = 15
- Primary endpoint
- Change in 14-day mean glucose by CGM, efficacy population
- Follow-up
- Baseline to end of treatment at 14 weeks
Methodological detailssingle-centre, double-blind, parallel-group, placebo-controlled, 8-week semaglutide or placebo run-in (0.25 mg then 0.50 mg weekly), then 6 weeks of GIP or placebo infusion
- Single-centre
- Double-blind
- Parallel-group
- Placebo-controlled
- 8-week semaglutide or placebo run-in (0.25 mg then 0.50 mg weekly), then 6 weeks of GIP or placebo infusion
Primary result
As reported in the abstract
Estimated effect
0.80 mmol/L
97.5% CI −0.18 to 1.80P = 0.13
Placebo plus GIP vs Placebo plus placebo
Estimated effect
0.05 mmol/L
97.5% CI −0.85 to 0.95P = 1.00
Semaglutide plus GIP vs Semaglutide plus placebo
Further findings
Fasting intact (bioactive) GIP · week 14
Fasting total GIP · week 14
Safety
Gastrointestinal AEs (more frequent with semaglutide)
Injection site reactions (most common AE)
- Injection site reactions, all participants
- 22 [36%]
Original publication
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