Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Newly Diagnosed Type 2 Diabetes

Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls

The efficacy, safety and post-treatment disease control will be compared between treatments consisting of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetic Patients
• Intervention / Treatment: Drug: Beinaglutide; Drug: Insulin aspart

Detailed Description

Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, we adopted a combinational therapeutic model and will administer drug treatments during basic meals. Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device. The efficacy, safety and disease control after terminating the drug treatments will be compared to those of patients who receive CSII treatment.

This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases:

a five-week treatment phase and a 48-week post-treatment follow-up period.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lixin Guo, Ph.D, M.D.; Phone Number: 13901317569; Email: glx1218@163.com
• Study Contact Backup: Name: Yan Zhou, Ph.D, M.D.; Phone Number: 13693033121; Email: 1430161933@qq.com

Study Locations

• China
  • China,Beijing
    • Beijing, China,Beijing, China, 100034
      • First Hospital of Peking University
      • Contact: Geheng Yuan, Ph.D. M.D.
  • China,Fuzhou
    • Fuzhou, China,Fuzhou, China, 350025
      • Ninth Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
      • Contact: Xiangjin Xu, Ph.D.M.D
  • China,Guangzhou
    • Guangzhou, China,Guangzhou, China, 510515
      • Southern Hospital of Southern Medical University
      • Contact: Yaoming Xue, Ph.D.M.D
  • China,Harbin
    • Harbin, China,Harbin, China, 150030
      • Heilongjiang Provincial Hospital
      • Contact: Binhong Duan, PH.D.M.D
  • China,Zhengzhou
    • Zhengzhou, China,Zhengzhou, China, 450003
      • Henan People's Hospital
      • Contact: Huijuan Yuan, Ph.D. M.D.
  • Hebei,Tangshan
    • Tangshan, Hebei,Tangshan, China, 063000
      • Tangshan Workers Hospital
  • Shandong，Qingdao
    • Qingdao, Shandong，Qingdao, China, 266000
      • Affiliated Hospital of Qingdao University
      • Contact: Yangang Wang, Ph.D.M.D
  • Sichuan，Sichuan
    • Luzhou, Sichuan，Sichuan, China, 646000
      • Affiliated Hospital of Southwest Medical University
      • Contact: Yong Xu, Ph.D.M.D
  • Zhejiang,Hangzhou
    • Hangzhou, Zhejiang,Hangzhou, China, 310014
      • Zhejiang People's Hospital
      • Contact: Yanyin Hua, Ph.D.M.D

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:

• Patients aged 18 to 70 years (including 18- and 70-year-olds) at the time of enrollment regardless of gender;
• Patients who are willing to sign the informed consent form voluntarily;
• Patients diagnosed with type 2 diabetes based on the WHO 1999 diagnostic criteria with a disease duration of < 1 year;
• Patients with HbA1c levels between 9% and 12.0% or fasting blood glucose levels greater than 11.1 mmol / L;
• Patients with BMIs between 24 and 45 kg / m2;
• Patients who have not taken or have taken hypoglycemic agents for less than a month or patients who are not receiving any ongoing systematic treatment with oral hypoglycemic drugs (have taken hypoglycemic drugs for less than three months in the past but have stopped taking drugs more than three months earlier);
• Fertile female patients (or male subjects with fertile female partners) who agree to use effective contraceptives throughout the course of the study until one full month after the last treatment dosage.

Exclusion Criteria:

• Patients with type 1 or other types of diabetes;
• Patients with a history of obstructive bowel disease or such possible complications; patients with intestinal adhesions or obstructions caused by abdominal surgery or peritoneal infection; patients with reduced intestinal motilities or habitual constipation or patients with histories of immunologically based inflammatory bowel disease (IBD), Crohn's disease (CD) or ulcerative colitis (UC);
• Past diagnosis of pancreatitis;
• Family history of medullary thyroid carcinoma;
• Patients with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels that are greater than 3 times the normal upper limit and/or bilirubin levels greater than 2 times the normal upper limit;
• Patients with an above-moderate degree of renal insufficiency (eGFR < 60 ml / min / 1.73 m2);
• Triglyceride levels ≥ 5.0 mmol / L;
• Multiple endocrine neoplasia 2 (MEN 2);
• Patients who have participated in a pre-market trial drug within the last three months;
• Patients receiving treatments with systemic hormones (including glucocorticoids), immunosuppressants or cytotoxic drugs or who are anticipating such treatments during the course of the study;
• Patients with severe ketosis or ketoacidosis less than one month prior to screening;
• Patients with blood pressure above the following values (untreated or after treatments): systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
• Within three months before the screening visit, patients have suffered one of following cardiovascular illnesses: acute myocardial infarction or congestive heart failure (cardiac functional capacity III/IV based on the New York Heart Association criteria or left ventricular ejection fraction ≤ 40%) or patients who have experienced cerebrovascular incidents (stroke);
• Patients with inflammatory bowel disease;
• Patients who are allergic to the test drug (Beinaglutide) or any of its other components and those who are allergic to the insulin reagent used in the study or any of its ingredients;
• Patients who have certain serious diseases that may interfere with the study and are not suitable to participate, as determined by the investigators;
• Pregnant women or women who are breastfeeding;
• Patients whose compliance is considered poor by the investigators, such that the study cannot be completed as required;
• Patients who are not suitable candidates to receive continuous pumping, such as those who are allergic to subcutaneous infusion tubes or tapes; those who are not willing to allow subcutaneous embedment of infusion tubes or to wear pumps for a long period of time; those who do not wish to receive medication via a pump; those who fail to master correct use after training sessions due to a lack of appropriate knowledge of the patients themselves or their family members; those with severe psychological or mental disorders or those who, without any guardians, are not capable of taking care of themselves;
• Patients who are not eligible to participate in this study due to factors identified by the investigators.

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; Five-week Beinaglutide pump treatment group	Drug: Beinaglutide; Five-week Beinaglutide pump treatment group
Experimental: Insulin aspart; Five-week short-term CSII (insulin aspart) treatment group	Drug: Insulin aspart; Five-week short-term CSII (insulin aspart) treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with at least a 0.7% change in the absolute value of glycated hemoglobin	The primary endpoint of the trial is a composite endpoint reflected by the percentage of patients with at least a 0.7% change in the absolute value of glycated hemoglobin and without hypoglycemia after 5 weeks of treatment.	Baseline and week5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
After five weeks of treatment, the differences in the percentages of patients with at least 3% weight loss	After five weeks of treatment, the differences in the percentages of patients with at least 3% weight loss (compared to their baseline weights) in the two treatment groups	Baseline and week5
The percentage of subjects whose blood glucose levels are within the normal range	The percentage of subjects whose blood glucose levels are within the normal range after five weeks of treatment	Baseline and week5
The time required for patients' blood glucose levels to reach the normal range	The time (days) required for patients' blood glucose levels to reach the normal range during the five-week treatment	Baseline and week5
Body weights of the two patient groups	Body weights of the two patient groups after the five-week treatment	Baseline and week5
Waist circumferences of the two patient groups	Waist circumferences of the two patient groups after the five-week treatment	Baseline and week5
BMIs of the two patient groups	BMIs of the two patient groups after the five-week treatment	Baseline and week5
Waist-to-hip ratios (WHRs) of the two patient groups	Waist-to-hip ratios (WHRs) of the two patient groups after the five-week treatment	Baseline and week5
Changes in the function of islet β-cells (HOMA-β)	Changes in the functions of islet β-cells in patients after five weeks of treatment (measured by the Homeostatic Model Assessment of β-cell function HOMA-β)	Baseline and week5
Changes in the function of islet β-cells (insulin index ΔI30 / ΔG30)	Changes in the functions of islet β-cells in patients after five weeks of treatment (measured by insulin index ΔI30 / ΔG30);	Baseline and week5
Changes in insulin sensitivity	Changes in insulin sensitivity in the two patient groups after five weeks of treatment (measured by the Homeostatic Model Assessment of Insulin Resistance - HOMA-IR).	Baseline and week5
Changes in β-cell function (HOMA-β)	After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: HOMA-β changes at week 53 from baseline	Baseline and week53
Weight changes between the two treatment groups	After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: weight changes at week 53 from baseline	Baseline and week53
Weight changes between the two treatment groups	After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: weight changes at week 53 from week 5	week5 and week53
The percentage of responders who meet the HbA1c criteria	The percentage of responders who meet the HbA1c criteria at week 53 will be compared between the Beinaglutide-treated group and the insulin aspart-treated group	Baseline and week53
The differences in the duration of target blood glucose levels that are met	The difference in the duration during which the criteria of blood glucose levels are met will be compared	Baseline and week53
The percentages of responders who meet the HbAc1 criteria	The percentages of responders who meet the HbAc1 criteria at week 17 from the end of treatments will be compared	week5 and week17
Weight changes between the two treatment groups	The percentages of responders who meet the weight changes at week 17 from the end of treatments will be compared	week5 and week17
Differences in HbA1c indices	Analyze the differences in HbA1c indices for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria after 5-week treatment, respectively	Week5 and week29
Differences in weight	Analyze the differences in weight for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria after 5-week treatment, respectively	Week5 and week29
Differences in HbA1c indices	Analyze the differences in HbA1c indices for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively	Week5 and week53
Differences in weight	Analyze the differences in weight for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively	Week5 and week53
Differences in insulin levels	Analyze the differences in insulin for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively	Week5 and week53
Differences in C-peptide levels	Analyze the differences in C-peptide for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively	Week5 and week53
The percentages of subjects with greater than 3% weight loss	The percentages of subjects with weight loss at week 53 from baseline greater than 3% will be compared between the two treatment groups	Baseline and week53

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Type 2 diabetic patients; Beinaglutide injection solution; Insulin aspart injection solution
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: BN-IIT-IS-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No