A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
- Registration Number
- NCT02059564
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
- Detailed Description
Primary Objective
- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying
Secondary Objectives
* evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test
* evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide
* evaluate safety and tolerability of different doses of HM11260C and liraglutide
* evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
- History of type 2 diabetes
- Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
- Use of approved methods of contraception
- Ability to provide written informed consent
- Type 1 diabetes
- Significant acute diabetic proliferative retinopathy or severe neuropathy
- Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to randomization
- History of any major surgery within 6 months prior to Screening
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- History of renal disease or significantly abnormal kidney function tests at Screening
- History of hepatic disease or significantly abnormal liver function tests
- History of any active infection within 30 days prior to Randomization
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
- Donation or loss of >500 mL of blood or blood product within 56 days of Randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A HM11260C The weekly treatment of the 6 mg HM11260C or placebo will be maintained Cohort A Placebo The weekly treatment of the 6 mg HM11260C or placebo will be maintained Cohort B HM11260C The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg Cohort C Victoza The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg Cohort B Placebo The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
- Primary Outcome Measures
Name Time Method PK profile of acetaminophen 13 weeks Cmax, AUC at 13 weeks
- Secondary Outcome Measures
Name Time Method Glucose metabolism 13 weeks Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks
Safety and tolerability 18 weeks Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks
Trial Locations
- Locations (1)
Hanmi
🇺🇸California, California, United States