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The investigators aimed to assess the efficacy and safety of Beinaglutide versus glargine , in individuals with type 2 diabetes who did not achieve adequate glycaemic control with oral antidiabetic drug.
The investigators wonder in clinical hypoglycemic treatment for patients with hyperglycemia, whether to reduce fasting blood glucose or postprandial blood glucose first.
In this study, subjects with type 2 diabetes mellitus in combination with oral medication will be treated with basic insulin to reduce fasting blood glucose, or with beinaglutide to reduce postprandial blood glucose, in order to find out which one of controling blood glucose can be more effective and observe the change of blood fluctuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beinaglutide | Experimental |
|
|
| glargine | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beinaglutide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion and rate of the fasting blood glucose control. | Baseline and week 16 | |
| Proportion of patients with glycosylated hemoglobin < 7%. | Baseline and week 16 | |
| Changes of blood sugar variation . | Baseline and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change percentage of glycosylated hemoglobin | Baseline and week16 | |
| Change of blood glucose | Baseline and week16 | |
| Change of blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measure: Adverse Event | Adverse Event | From baseline to week 16 |
| Safety Outcome Measure: Serious adverse event | Serious adverse event |
Inclusion Criteria:
Exclusion Criteria:
Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods .
Current diagnosis or history of following:
Impaired liver function,such as manifested in one of the following situations:
Moderate to severe renal impairment or end-stage renal disease (estimated kidney) at visit or 4 weeks before visit (local data)Globular filtration rate < 60 mL/minNew York Heart Association (NYHA) Class III or IV congestive heart failure
Visit 1 has a major history of cardiovascular disease in the past three months, defined as myocardial infarction, coronary angioplasty or bypass surgery, valvular disease or repair, unstable angina, transient ischemic attack or cerebrovascular accident.
History of acute or chronic pancreatitis
History of gastrointestinal diseases, including gastrointestinal stoma anastomosis, intestinal resection, gastric cardiac syndrome, severe hernia, intestinal obstruction, intestinal ulcer
Malignant tumors (except cutaneous basal cell carcinoma, cervical carcinoma in situ and prostate cancer in situ) have been diagnosed in the past five years.
History of organ transplantation or AIDS
History of medullary thyroid cancer
History of alcohol or drug abuse in the past 12 months
Individuals or researchers who do not comply with the potential risks of the program are judged to be unsuitable for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang'an Hospital | Xi'an | China,Shanxi | 710016 | China | ||
| Shaanxi Aerospace Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37864379 | Derived | Liu X, Yang W, Liu J, Huang X, Fang Y, Ming J, Lai J, Fu J, Ji Q, Wang L. The efficacy and safety of beinaglutide alone or in combination with insulin glargine in Chinese patients with type 2 diabetes mellitus who are inadequately controlled with oral antihyperglycemic therapy: A multicenter, open-label, randomized trial. J Diabetes. 2023 Oct 20;16(2):e13483. doi: 10.1111/1753-0407.13483. Online ahead of print. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C061970 | glucagon-like peptide 1 (7-36) |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| glargine | Drug |
|
|
| Baseline and week16 |
| Change of blood lipids | Baseline and week16 |
| Change of body weight report in kilograms | Baseline and week16 |
| Change of body mass index report in kg/m^2 | Baseline and week16 |
| Waist-hip ration change | Baseline and week16 |
| Oxidative Stress Indice (8-Iso-PGF2α) change | Baseline and week16 |
| Inflammatory factors (MCP-1) change | Baseline and week16 |
| Inflammatory factors (hs-CRP) change | Baseline and week16 |
| From baseline to week 16 |
| Xi'an |
| China,Shanxi |
| 710025 |
| China |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |