Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents
Recruiting
Phase 4
Interventional Study
Type 2 Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,316 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Other
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About This Trial
This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. A total of 1,316 subjects from approximately 40 research centers…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
2. Type 2 diabetes mellitus diagnosis.
3. Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
4. HbA1c 7.5-11%
5. Furt…
Contacts