Type2 Diabetes Mellitus
Conditions
Keywords
rE-4, Exenatide, Metformin, Sulfonylurea
Brief summary
This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.
Detailed description
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two rE-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.
Interventions
BIOLOGICALrE-4 5 mcg
Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily
BIOLOGICALrE-4 10 mcg
Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily
BIOLOGICALPlacebo 5 mcg
Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily
BIOLOGICALPlacebo 10 mcg
Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. T2DM 2. 7.0% ≤ HbA1c ≤ 11.0% at screening 3. FPG ≤13.8 mmol/L 4. 19 kg/m2 \< BMI \<35.0 kg/m2 at screening 5. All subjects provided written informed consent before participation
Exclusion criteria
1. T1DM 2. Patients treated previously with Exenatide or GLP-1 similar 3. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN 4. At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L 5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases 6. Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period 7. History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones) 8. Patients with severe renal impairment or end-stage renal disease 9. Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit. 10. Use of weight loss drugs within 3 months prior to screening visit 11. Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening. 12. Severe gastrointestinal disease (e.g., gastroparesis) 13. Pregnancy or lactation, women of childbearing potential with no effective contraceptive method 14. Participant who participated in any drug clinical trial within the last 3 months prior to screening visit 15. History of severe hypersensitivity to rExenatide-4 or any product components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from Baseline to Week 30 | Baseline (Day 1) to Week 30 | Change in HbA1c from Baseline (Day 1) to study termination (Week 30) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30 | Baseline (Day 1) and Week 30 | The number of subjects achieving HbA1c target values of \< 7% and ≤ 6.5% by study termination (Week 30) |
| Change in body weight from Baseline to each intermediate visit and Week 30 | Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30 | Change in body weight (kg) from Baseline to each intermediate visit and Week 30 |
| Change in FPG from Baseline to each intermediate visit and Week 30 | Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 | Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30 |
| Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30 | Baseline, Week 16，Week 24 and Week 30 | Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16，Week 24 and Week 30 |
Contacts
Primary Contactlinong Ji, Ph.D
Outcome results
None listed