Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.
Detailed description
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.
Interventions
DRUGPB-119 75ug
60 eligible patients will be included in this group
DRUGPB-119 150ug
60 eligible patients will be included in this group
DRUGPB-119 200ug
60 eligible patients will be included in this group
DRUGplacebo
60 eligible patients will be included in this group
Sponsors
Tigermed Consulting Co., Ltd
PegBio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Males and/or females between the ages of ≥18 and ≤70 years at Screening 2. Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria 3. HbA1c ≥7.5% and ≤11% at Screening and at Week -1 4. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening
Exclusion criteria
1. Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial 2. Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness 3. Calcitonin ≥50 ng/L at screening 4. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2 5. Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening 6. Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial 7. Blood amylase or lipase \>3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening 8. Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 at Screening 9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2x upper limit of normal (ULN) at Screening and pre-randomization 10. Severe cardiovascular diseases occurring within 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of glycosylated hemoglobin(HbA1c) | 12 weeks | Change of HbA1c from baseline value to end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 2, 4, and 8 weeks | Changes of HbA1c from baseline value at Weeks 2, 4, and 8 |
| 2-hour postprandial glucose(2-h PPG) | 4, 8, and 12 weeks | Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12. |
| Insulin | 4, 8, and 12 weeks | Changes of insulin from baseline value at Weeks 4, 8, and 12 |
| C-peptide | 4, 8, and 12 weeks | Changes of C-peptide from baseline value at Weeks 4, 8, and 12 |
| Self-monitoring of blood glucose (SMBG) | 4, 8, and 12 weeks | Changes of mean profile and mean increments from baseline value of the 7-point SMBG |
| Percentage of patients achieving HbA1c <7% | 12 weeks | Percentage of patients achieving HbA1c \<7% at Week 12 |
| Percentage of patients achieving HbA1c ≤6.5% | 12 weeks | Percentage of patients achieving HbA1c ≤6.5% at Week 12 |
| Fasting plasma glucose(FPG) | 2, 4, 8, and 12 weeks | Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure(both systolic and diastolic) | 2, 4, 8, and 12 weeks | Changes of blood pressure from baseline value at Weeks 2, 4, 8, and 12. |
| Blood lipid | 2, 4, 8, and 12 weeks | Changes of blood lipid from baseline value at Weeks 2, 4, 8, and 12 |
| Body mass index(BMI) | 2, 4, 8, and 12 weeks | Changes of BMI from baseline value at Weeks 2, 4, 8, and 12. |
| Waist and hip circumferences and waist-to-hip ratio | 12 weeks | Change of waist and hip circumferences and waist-to-hip ratio from baseline value at end of treatment(waist and hip circumferences will be used to calculate waist-to-hip ratio |
Countries
China
Outcome results
None listed