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

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: HM11260C; Drug: Victoza

Study type: Interventional

Funder types: Industry

Identifiers

NCT02059564

HM-EXC-102

Details and patient eligibility

About

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

Full 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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 3 patient groups

Cohort A

Experimental group

Description:

The weekly treatment of the 6 mg HM11260C or placebo will be maintained

Treatment:

Drug: HM11260C

Drug: Placebo

Cohort B

Experimental group

Description:

The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg

Treatment:

Drug: HM11260C

Drug: Placebo

Cohort C

Experimental group

Description:

The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg

Treatment:

Drug: Victoza