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

Type 2 Diabetic Patients Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03987308
• Other study ID #: BN-IIT-IS-008
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2019
• Source: Beijing Hospital
• Contact: Lixin Guo, Ph.D, M.D.
• Phone: 13901317569
• Email: glx1218[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetic Patients

Intervention

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

Locations

Country	Name	City	State
China	First Hospital of Peking University	Beijing	China,Beijing
China	Ninth Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army	Fuzhou	China,Fuzhou
China	Southern Hospital of Southern Medical University	Guangzhou	China,Guangzhou
China	Zhejiang People's Hospital	Hangzhou	Zhejiang,Hangzhou
China	Heilongjiang provincial hospital	Harbin	China,Harbin
China	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan,Sichuan
China	Affiliated Hospital of Qingdao University	Qingdao	Shandong,Qingdao
China	Tangshan Workers Hospital	Tangshan	Hebei,Tangshan
China	Henan People's Hospital	Zhengzhou	China,Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Body weights of the two patient groups	Body weights of the two patient groups after the five-week treatment	Baseline and week5
Secondary	Waist circumferences of the two patient groups	Waist circumferences of the two patient groups after the five-week treatment	Baseline and week5
Secondary	BMIs of the two patient groups	BMIs of the two patient groups after the five-week treatment	Baseline and week5
Secondary	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
Secondary	Changes in the function of islet ß-cells (HOMA-ß)	Changes in the functions of islet ß-cells in patients after five weeks of treatment (measured by the Homeostatic Model Assessment of ß-cell function HOMA-ß)	Baseline and week5
Secondary	Changes in the function of islet ß-cells (insulin index ?I30 / ?G30)	Changes in the functions of islet ß-cells in patients after five weeks of treatment (measured by insulin index ?I30 / ?G30);	Baseline and week5
Secondary	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
Secondary	Changes in ß-cell function (HOMA-ß)	After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: HOMA-ß changes at week 53 from baseline	Baseline and week53
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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