Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: The FOCUS Randomized Clinical Trial
Errata to this article were published (JAMA Intern Med, 1 Sep 2024 ↗ · 1 Oct 2024 ↗)
Primary result · DiabetesResult — go to the resultHazard ratio 0.59 95% CI 0.46–0.74Authors' conclusion
The findings suggest that JLD can reduce the risk of diabetes in participants with IGT and multiple metabolic abnormalities.
Study context
- Population
- Individuals aged 18 to 70 years with impaired glucose tolerance (IGT) and multiple metabolic abnormalities; 35 centers in 21 cities in China, June 2019 to February 2023; mean (SD) age 52.57 (10.33) years, 52.32% female885 in full analysis set
- Participants
- 889 individuals
- Comparison
- Jinlida granules vs placebo
- Jinlida (JLD)n = 442
- Placebon = 443reference
- Primary endpoint
- Occurrence of diabetes, determined by 2 consecutive OGTTs
- Follow-up
- Median observation 2.20 years (IQR, 1.27-2.64 years)
Methodological detailsmulticenter, double-blind, placebo-controlled
- Multicenter
- Double-blind
- Placebo-controlled
Primary result
Diabetes · median 2.20 years
Hazard ratio
0.59
95% CI 0.46–0.74
P < 0.001
JLDvs Placebo
HR 0.59 (95% CI 0.46–0.74); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Between-group difference (cm) (95% CI) | |
|---|---|---|
| Waist circumference · follow-up period | 0.95 (0.36–1.55) | |
| −1012Difference, cm (linear scale) |
| Outcome | Between-group difference (mg/dL) (95% CI) | |
|---|---|---|
| 2-hour postprandial blood glucose · follow-up period | 9.2 (5.4–13.0) | |
| Fasting blood glucose · follow-up period | 3.8 (2.2–5.6) | |
| Total cholesterol · follow-up period | 6.6 (1.9–11.2) | |
| LDL-C · follow-up period | 4.3 (0.8–7.7) | |
| Triglycerides · follow-up period | 25.7 (15.9–35.4) | |
| −2002040Difference, mg/dL (linear scale) |
| Outcome | Between-group difference (%) (95% CI) | |
|---|---|---|
| HbA1c · follow-up period | 0.20 (0.13%–0.27%) | |
| −0.200.20.4Difference, % (linear scale) |
| Outcome | Between-group difference (95% CI) | |
|---|---|---|
| HOMA-IR · follow-up period | 0.47 (0.12–0.83) | |
| −0.500.51Difference (linear scale) |
Ankle-brachial index and waist circumference · 24 months
- Significant improvement in ankle-brachial index and waist circumference with JLD vs placebo
Original publication
Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities: The FOCUS Randomized Clinical Trial. JAMA Intern Med. Published 1 July 2024. doi:10.
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