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

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ClinicalTrials.gov Identifier: NCT03987308
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetic Patients Drug: Beinaglutide Drug: Insulin aspart Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The percentage of patients with at least a 0.7% change in the absolute value of glycated hemoglobin [ Time Frame: Baseline and week5 ]
    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.


Secondary Outcome Measures :
  1. After five weeks of treatment, the differences in the percentages of patients with at least 3% weight loss [ Time Frame: Baseline and week5 ]
    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

  2. The percentage of subjects whose blood glucose levels are within the normal range [ Time Frame: Baseline and week5 ]
    The percentage of subjects whose blood glucose levels are within the normal range after five weeks of treatment

  3. The time required for patients' blood glucose levels to reach the normal range [ Time Frame: Baseline and week5 ]
    The time (days) required for patients' blood glucose levels to reach the normal range during the five-week treatment

  4. Body weights of the two patient groups [ Time Frame: Baseline and week5 ]
    Body weights of the two patient groups after the five-week treatment

  5. Waist circumferences of the two patient groups [ Time Frame: Baseline and week5 ]
    Waist circumferences of the two patient groups after the five-week treatment

  6. BMIs of the two patient groups [ Time Frame: Baseline and week5 ]
    BMIs of the two patient groups after the five-week treatment

  7. Waist-to-hip ratios (WHRs) of the two patient groups [ Time Frame: Baseline and week5 ]
    Waist-to-hip ratios (WHRs) of the two patient groups after the five-week treatment

  8. Changes in the function of islet β-cells (HOMA-β) [ Time Frame: Baseline and week5 ]
    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)

  9. Changes in the function of islet β-cells (insulin index ΔI30 / ΔG30) [ Time Frame: Baseline and week5 ]
    Changes in the functions of islet β-cells in patients after five weeks of treatment (measured by insulin index ΔI30 / ΔG30);

  10. Changes in insulin sensitivity [ Time Frame: Baseline and week5 ]
    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).

  11. Changes in β-cell function (HOMA-β) [ Time Frame: Baseline and week53 ]
    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

  12. Weight changes between the two treatment groups [ Time Frame: Baseline and week53 ]
    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

  13. Weight changes between the two treatment groups [ Time Frame: week5 and week53 ]
    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

  14. The percentage of responders who meet the HbA1c criteria [ Time Frame: Baseline and week53 ]
    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

  15. The differences in the duration of target blood glucose levels that are met [ Time Frame: Baseline and week53 ]
    The difference in the duration during which the criteria of blood glucose levels are met will be compared

  16. The percentages of responders who meet the HbAc1 criteria [ Time Frame: week5 and week17 ]
    The percentages of responders who meet the HbAc1 criteria at week 17 from the end of treatments will be compared

  17. Weight changes between the two treatment groups [ Time Frame: week5 and week17 ]
    The percentages of responders who meet the weight changes at week 17 from the end of treatments will be compared

  18. Differences in HbA1c indices [ Time Frame: Week5 and week29 ]
    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

  19. Differences in weight [ Time Frame: Week5 and week29 ]
    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

  20. Differences in HbA1c indices [ Time Frame: Week5 and week53 ]
    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

  21. Differences in weight [ Time Frame: Week5 and week53 ]
    Analyze the differences in weight for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively

  22. Differences in insulin levels [ Time Frame: Week5 and week53 ]
    Analyze the differences in insulin for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively

  23. Differences in C-peptide levels [ Time Frame: Week5 and week53 ]
    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

  24. The percentages of subjects with greater than 3% weight loss [ Time Frame: Baseline and week53 ]
    The percentages of subjects with weight loss at week 53 from baseline greater than 3% will be compared between the two treatment groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987308


Contacts
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Contact: Lixin Guo, Ph.D, M.D. 13901317569 glx1218@163.com
Contact: Yan Zhou, Ph.D, M.D. 13693033121 1430161933@qq.com

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

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Responsible Party: Beijing Hospital
ClinicalTrials.gov Identifier: NCT03987308     History of Changes
Other Study ID Numbers: BN-IIT-IS-008
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beijing Hospital:
Type 2 diabetic patients
Beinaglutide injection solution
Insulin aspart injection solution

Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs