CALL US: 1-855-483-4325

A Phase II, 16-week, double-blind, placebo-controlled, parallel-group, randomized, multicenter trial to assess effect on glycaemic control of three doses of HM11260C in subjects with inadequately controlled type 2 diabetes receiving a stable dose of metformin

Purpose

The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered monthly under the skin, to improve the control of blood sugar levels in patients with inadequately controlled T2DM who are receiving a stable dose of metformin. The optimal dose will be determined based on the efficacy (effects on HbA1c), safety and tolerability of three HM11260C doses compared with placebo. Data from this study will be used to assist in the design of the Phase 3 study, which will assess the safety and effectiveness of HM11260C as a treatment to improve the control of blood sugar levels in patients with T2DM. Primary objective is to assess and compare the efficacy of three doses of HM11260C (once monthly dosing) versus placebo on glycaemic control as assessed by the change in HbA1c over the 16 weeks from baseline in subjects with T2DM receiving a stable dose of metformin.

Keywords

glycaemic, HM11260C, type 2 diabetes, metformin, blood sugar

Principal Investigator

Mae Sheikh-Ali

Department

JAX MEDICINE-GENERAL

Contact Information

Mae.sheikh-ali@jax.ufl.edu
9042448840

Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at CTSI-Studies-L@lists.ufl.edu.

Other Resources

  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams