Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

NCT ID: NCT03829891

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2020-12-04

Brief Summary

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.

Detailed Description

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Beinaglutide

1. Beinaglutide for 8 weeks,

2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )

Group Type: EXPERIMENTAL

Beinaglutide

Intervention Type: DRUG

1. Beinaglutide for 8 weeks,

2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )

glargine

Intervention Type: DRUG

1. Glargine for 8 weeks,

2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )

glargine

1. Glargine for 8 weeks,

2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )

Group Type: ACTIVE_COMPARATOR

Beinaglutide

Intervention Type: DRUG

1. Beinaglutide for 8 weeks,

2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )

glargine

Intervention Type: DRUG

1. Glargine for 8 weeks,

2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )

Interventions

Beinaglutide

1. Beinaglutide for 8 weeks,

2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )

Intervention Type: DRUG

glargine

1. Glargine for 8 weeks,

2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent obtained before any trial-related activities
• Male or female between the age of 18 and 70 years by the time of visit 1
• Have been diagnosed as type 2 diabetes for at least half a year
• Prestudy combination OAD therapy for at least 1 month(except glinides, DPP-VI inhibitor,insulin,GLP-1 receptor agonists ),
• The dose of Sulfonylureas less than the half maximum dose of insert
• 7.5%≤HbA1c≤11.0% in recent 2 weeks or on visit 1(local lab test)
• 21Kg/m2≤BMI≤35Kg/m2

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:

• Type 1 diabetes
• Diabetes caused by impaired pancreas
• Diabetes is the secondary diagnosis ,such as acromegaly,Cushing syndrome etc.
• Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg. diabetes ketoacidosis, hyperosmolar coma) within 6months prior to screening.
• Use of any glinides, DPP-VI inhibitor,GLP-1 receptor agonists within 3months prior to screening.Use of any insulin within 1months prior to screening.
• History of allergy (such as systemic allergy, Vascular neuroedema, epidermal exfoliation, etc.)
• Systemic use of glucocorticoids (oral or intravenous) continued for more than seven days in the past half year.
• Triglyceride (fasting)> 4.5mmol/L at visit 1.
• Impaired liver function,such as manifested in one of the following situations:

• Two consecutive measurements of AST or ALT in the first four weeks of the visit exceeded the maximum normal value by more than three times (local laboratory data)
• Bilirubin synthesis and/or excretion disorders (such as hyperbilirubinemia) and other decompensated liver diseases such as coagulation,Blood disorders, hepatic encephalopathy, hypoproteinemia, ascites, esophageal variceal bleeding
• Acute viral, active autoimmune, alcoholic and other types of hepatitis
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang'an Hospital

Xi'an, China,Shanxi, China

Shaanxi Aerospace Hospital

Xi'an, China,Shanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37864379 (View on PubMed)

Other Identifiers

KY20182008-1

Identifier Type: -

Identifier Source: org_study_id