Safety and Efficacy of YH14617 in Diabetes Mellitus

Yuhan

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: YH14617

Study type: Interventional

Funder types: Industry

Identifiers

NCT01507038

YH14617-201

Details and patient eligibility

About

The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.

Enrollment: 84 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have signed a written informed consent voluntary, prior to the any procedure
• Volunteers of aged between 20 years to 75 years
• Have been diagnosed with type 2 diabetes at least 3 months prior to study
• Have a body mass index (BMI) of > 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by > 5% in weight)
• Have been treated with stable dose regimen of Metformin > 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration
• Have an HbA1c between 7% and 10% inclusive

Exclusion criteria

• Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration
• Have acute disease, other untreated disease or diabetic complications that needs additional treatment
• Have severe renal disorder(serum creatinine concentration > 1.5 times of normal upper limit) or liver disorder(liver enzyme > 2 times of normal upper limit)
• Have blood pressure > 160/100mmHg
• Have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration
• Have history of critical disease within 1 year prior to the first administration
• Have untreated malignant tumor or have history of significant malignant tumor within 5 years prior to the first administration
• Have fasting plasma glucose(FPG) > 250mg/dl or have random glucose level > 350mg/dl
• Have more than 1 history of severe hypoglycemia that needed others help within 3 months prior to the first administration
• Have a known allergy or hypersensitivity to drugs
• Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
• Participated in any other clinical trials within 30 days prior to the first administration
• Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons other than above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Treatment:

Drug: YH14617

Drug: YH14617

Drug: YH14617

Group B

Experimental group

Treatment:

Drug: YH14617

Drug: YH14617

Drug: YH14617

Group C

Experimental group

Treatment:

Drug: YH14617

Drug: YH14617

Drug: YH14617

Group D

Placebo Comparator group

Treatment:

Drug: Placebo