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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829891
• Other study ID #: KY20182008-1
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: December 4, 2020

Study information

• Verified date: August 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 4, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Beinaglutide
Beinaglutide for 8 weeks, Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )
• glargine
Glargine for 8 weeks, Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )

Locations

Country	Name	City	State
China	Chang'an Hospital	Xi'an	China,Shanxi
China	Shaanxi Aerospace Hospital	Xi'an	China,Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome Measure: Adverse Event	Adverse Event	From baseline to week 16
Other	Safety Outcome Measure: Serious adverse event	Serious adverse event	From baseline to week 16
Primary	The proportion and rate of the fasting blood glucose control.		Baseline and week 16
Primary	Proportion of patients with glycosylated hemoglobin < 7%.		Baseline and week 16
Primary	Changes of blood sugar variation .		Baseline and week 16
Secondary	Change percentage of glycosylated hemoglobin		Baseline and week16
Secondary	Change of blood glucose		Baseline and week16
Secondary	Change of blood pressure		Baseline and week16
Secondary	Change of blood lipids		Baseline and week16
Secondary	Change of body weight report in kilograms		Baseline and week16
Secondary	Change of body mass index report in kg/m^2		Baseline and week16
Secondary	Waist-hip ration change		Baseline and week16
Secondary	Oxidative Stress Indice (8-Iso-PGF2a) change		Baseline and week16
Secondary	Inflammatory factors (MCP-1) change		Baseline and week16
Secondary	Inflammatory factors (hs-CRP) change		Baseline and week16