Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM11260C (0.3 mg) | Experimental | Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks |
|
| HM11260C (1 mg) | Experimental | Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks |
|
| HM11260C (2 mg) | Experimental | Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks |
|
| HM11260C (3 mg) | Experimental | Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks |
|
| HM11260C (4 mg) | Experimental | Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks |
|
| Placebo | Placebo Comparator | Weekly administration of placebo by subcutaneous injection for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM11260C | Drug | HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks | Up to 127 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose levels (FPG) | Up to 127 days | |
| 7-point glucose profile | Up to day 127 | |
| Other glycaemic control parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of HM11260C | Up to day 127 | |
| Assess the immunogenicity of HM11260C | Up to day 127 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hanmi Pharmaceutical | clinical4@hanmi.co.kr | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi pharmaceutical | CA | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31320446 | Derived | Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH. Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide. Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18. |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Liraglutide | Active Comparator | Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg. |
|
|
| liraglutide | Drug | Liraglutide is a GLP-1 agonist. |
|
|
| Placebo | Drug | Placebo |
|
| Up to day 127 |
| Serum lipid profile | Up to day 127 |
| Body weight | Up to day 127 |
| Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7% | Up to 127 days |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |