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

A Randomized, Open-label, Controlled,Parallel-group Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Beinaglutide; Drug: glargine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • China,Shanxi
    • Xi'an, China,Shanxi, China, 710016
      • Chang'an Hospital
    • Xi'an, China,Shanxi, China, 710025
      • Shaanxi Aerospace Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beinaglutide; Beinaglutide for 8 weeks,; Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )	Drug: Beinaglutide; Beinaglutide for 8 weeks,; Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard ); Drug: glargine; Glargine for 8 weeks,; Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )
Active Comparator: glargine; Glargine for 8 weeks,; Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )	Drug: Beinaglutide; Beinaglutide for 8 weeks,; Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard ); Drug: glargine; Glargine for 8 weeks,; Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Other Outcome Measures

Outcome Measure	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	From baseline to week 16

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 4, 2020

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; glycemic variability; Beinaglutide
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: KY20182008-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No