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

NCT03829891 | Completed DMC

• 1 other identifier: KY20182008-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Beinaglutide; glycemic variability

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Change percentage of glycosylated hemoglobin

  Baseline and week16

• Change of blood glucose

  Baseline and week16

• Change of blood pressure

  Baseline and week16

• Change of blood lipids

  Baseline and week16

• Change of body weight report in kilograms

  Baseline and week16

Other Outcomes (2)

• Safety Outcome Measure: Adverse Event

  From baseline to week 16

• Safety Outcome Measure: Serious adverse event

  From baseline to week 16

Study Arms (2)

Beinaglutide

EXPERIMENTAL

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

Drug: Beinaglutide; Drug: glargine

glargine

ACTIVE COMPARATOR

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

Drug: Beinaglutide; Drug: glargine

Interventions

Beinaglutide DRUG

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

Beinaglutide; glargine

glargine DRUG

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

Beinaglutide; glargine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• %≤HbA1c≤11.0% in recent 2 weeks or on visit 1(local lab test)
• Kg/m2≤BMI≤35Kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (2)

Chang'an Hospital

Xi'an, China,Shanxi, 710016, China

Location

Shaanxi Aerospace Hospital

Xi'an, China,Shanxi, 710025, China

Location

Related Publications (1)

• 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.

  PMID: 37864379 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glucagon-like peptide 1 (7-36); Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: February 4, 2019
• Study Start: August 7, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 4, 2020
• Last Updated: January 19, 2022

Record last verified: 2020-08

Locations

CN (2)