HTD1801 in Combination with Metformin for Type 2 Diabetes
Authors' conclusion
After 24 weeks, HbA1c reduction was significantly greater among patients with T2D taking metformin and randomly assigned to receive HTD1801 versus placebo. A higher proportion of patients in the HTD1801 group experienced mild to moderate diarrhea compared with the placebo group.
Study context
- Population
- Patients with T2D, HbA1c 7.0% to 10.5%, fasting glucose ≤250.5 mg/dl, on stable metformin for ≥8 weeksrandomized 2:1
- Participants
- 365 vs 184
- Comparison
- HTD1801 vs placebo, added to metformin
- HTD1801n = 365
- Placebon = 184reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsphase 3, double-blind, placebo-controlled, add-on to metformin
- Phase 3
- Double-blind
- Placebo-controlled
- Add-on to metformin
Primary result
As reported in the abstract
Change in HbA1c from baseline · week 24 HTD1801 mean change −1.2 (95% CI −1.3–-1.1) percentage points · Placebo mean change −0.7 (95% CI −0.8–-0.6) percentage point
Mean HbA1c at baseline
Mean HbA1c at 24 weeks
Further findings
HbA1c at baseline
HbA1c at 24 weeks
Safety
Diarrhea (most common adverse event) · 24 weeks
- Diarrhea (most common adverse event) — Severe diarrhea cases in HTD1801; all other cases mild to moderate
- 3
Severe hypoglycemia · 24 weeks
- Patients with severe hypoglycemia
- 0
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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