Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia: multicentre, open label, randomised trial
Primary result · HbA1c <7.0%Result — go to the resultOdds ratio 2.78 95% CI 1.37–5.65Authors' conclusion
The intense simplified strategy using subsequent oral therapies post-SIIT, especially the linagliptin plus metformin combination, sustainably improved glycaemic control and β cell function in patients with newly diagnosed type 2 diabetes mellitus and severe hyperglycaemia. This approach offers a promising direction for decision making in the clinical management of type 2 diabetes mellitus.
Study context
- Population
- Newly diagnosed T2D with severe hyperglycaemia (HbA1c ≥8.5%), 15 hospitals in China; mean age 46.8 years, mean HbA1c 11.0%randomised
- Participants
- 412 participants
- Comparison
- Linagliptin, metformin, or linagliptin plus metformin vs lifestyle modification alone, each after SIIT
- Primary endpoint
- Percentage of participants achieving HbA1c <7.0%
- Follow-up
- Week 48 after SIIT
Methodological detailsmulticentre, open label
- Multicentre
- Open label
Primary result
HbA1c <7.0% · week 48
Odds ratio
2.78
95% CI 1.37–5.65
P = 0.005
Events by treatment group
As reported in the abstract
- Overall difference across groups
- P = 0.02 overall
Secondary outcomes
HbA1c <6.5% — Linagliptin plus metformin vs Control
P = 0.005 for linagliptin plus metformin versus control
| Outcome | P value |
|---|---|
| HbA1c <6.5%Linagliptin vs Control | P = 0.01 for linagliptin versus control |
| HbA1c <6.5%Metformin vs Control | P = 0.008 for metformin versus control |
- HbA1c <6.5% — Overall difference across groups
- P=0.005 overall
- HbA1c <6.5%: all were significant after adjustment for multiple comparisons
FPG and β cell function indices
- Linagliptin plus metformin showed the most significant improvement in FPG and β cell function indices
Safety
Tolerability
- All treatments were well tolerated
Original publication
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