A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus | RxWiki

A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Overview[ - collapse ][ - ]

Purpose	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
Condition	Diabetes Mellitus
Intervention	Drug: HM11260C Drug: Placebo Drug: Victoza
Phase	Phase 1
Sponsor	Hanmi Pharmaceutical Company Limited
Responsible Party	Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier	NCT02059564
First Received	February 5, 2014
Last Updated	February 7, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	February 5, 2014
Last Updated Date	February 7, 2014
Start Date	December 2013
Estimated Primary Completion Date	December 2014
Current Primary Outcome Measures	PK profile of acetaminophen [Time Frame: 13 weeks] [Designated as safety issue: No]Cmax, AUC at 13 weeks
Current Secondary Outcome Measures	Glucose metabolism [Time Frame: 13 weeks] [Designated as safety issue: No]Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks Safety and tolerability [Time Frame: 18 weeks] [Designated as safety issue: No]Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks

Descriptive Information[ + expand ][ + ]

Brief Title	A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Official Title	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
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
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Diabetes Mellitus
Intervention	Drug: HM11260C doses of 6 mg, 16 mg Other Names: LAPS-Exendin-4Drug: Placebo Normal saline solution Other Names: Normal saline solutionDrug: Victoza doses of 1.8 mg Other Names: Liraglutide
Study Arm (s)	Experimental: Cohort A The weekly treatment of the 6 mg HM11260C or placebo will be maintained Experimental: Cohort B The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg Experimental: Cohort C The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	44
Estimated Completion Date	December 2014
Estimated Primary Completion Date	October 2014
Eligibility Criteria	Inclusion Criteria: - 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 Exclusion Criteria: - 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Hanmi Clinical clinical4@hanmi.co.kr
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02059564
Other Study ID Numbers	HM-EXC-102
Has Data Monitoring Committee	No
Information Provided By	Hanmi Pharmaceutical Company Limited
Study Sponsor	Hanmi Pharmaceutical Company Limited
Collaborators	Not Provided
Investigators	Principal Investigator: Hanmi Clinical California, United States
Verification Date	February 2014

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