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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Peking University First Hospital | OTHER |
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This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial.
Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. Subjects should be in hospital for pharmacokinetic studies in 1 d~ 8d, 30 d (if necessary)and 84 d, during 9 d ~ 83 d outpatient follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator |
| |
| exenatide-4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rExenatide-4 | Biological | This protein of 39 amino acids has been isolated from the venom of the lizard Heloderma suspectum (Gila monster) (Eng et al, 1992). A mammalian homolog does not seem to exist (Pohl and Wank, 1998). Exendin-4 shares 53 % identity at the amino acid level with that of the mammalian hormone GLP-1 [glucagon-like peptide-1] (Chen and Drucker, 1997). Exendin-4 is encoded within a prohormone that is distinct from the prohormone encoding glucagon. Using transgenic mice expressing exendin-4, Adatia et al (2002) have shown that mammalian cells process the lizard prohormone in endocrine and nonendocrine cell types in vitro and in murine tissues in vivo. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare treatment arms in terms of change from baseline to endpoint in HbA1c | To observe and compare the differences in pharmacokinetic parameters with the reatment of rE-4, adding metformin to rE-4 and exenatide, To compare treatment arms in terms of change from baseline to endpoint in HbA1c | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare treatment arms in terms of change from baseline to endpoint in GA | 12 Weeks | |
| To compare treatment arms in terms of change from baseline to endpoint in fasting serum glucose | 12 Weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cui Yi Min, MD | Contact | 86-10-88325988 |
| Name | Affiliation | Role |
|---|---|---|
| Cui Yi min, MD | Peking University First Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28932995 | Derived | Wang Y, Xu B, Zhu L, Lou K, Chen Y, Zhao X, Wang Q, Xu L, Guo X, Ji L, Cui Y, Fang Y. Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus. Clin Drug Investig. 2017 Dec;37(12):1107-1115. doi: 10.1007/s40261-017-0569-1. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| To compare treatment arms in terms of change from baseline to endpoint in postprandial blood glucose 2-hour |
| 12 weeks |
| To compare treatment arms in terms of change from baseline to endpoint in body weight | 12 weeks |