Recruiting
Phase 1

LAPS-Exendin

Sponsor:

Hanmi Pharmaceutical Company Limited

Code:

NCT02059564

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

HM11260C

Placebo

Victoza

Study Details

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

Conditions

Diabetes Mellitus

Study ID

NCT02059564

Start date

Dec, 2013

Status verified date

Feb, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Oct, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

HM11260C

doses of 6 mg, 16 mg

Placebo

Normal saline solution

Victoza

doses of 1.8 mg

Primary outcome measure

  • PK profile of acetaminophen [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Hanmi Clinical

clinical4@hanmi.co.kr

Locations

Hanmi

Recruiting

California, California, United States

Contacts

Hanmi Clinical

clinical4@hanmi.co.kr

Principal Investigator:

Hanmi Clinical

More Information

Sponsor

Hanmi Pharmaceutical Company Limited

Last update posted

Feb 11, 2014

Last verified

Feb, 2014

Keywords

  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
  • Exendin-4

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited on 2014-02-11.