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

February 7, 2014 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • California, California, United States
        • Recruiting
        • Hanmi
        • Principal Investigator:
          • Hanmi Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
The weekly treatment of the 6 mg HM11260C or placebo will be maintained
Drug: Placebo
Normal saline solution
Other Names:
  • Normal saline solution
Drug: HM11260C
doses of 6 mg, 16 mg
Other Names:
  • LAPS-Exendin-4
Experimental: Cohort B
The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
Drug: Placebo
Normal saline solution
Other Names:
  • Normal saline solution
Drug: HM11260C
doses of 6 mg, 16 mg
Other Names:
  • LAPS-Exendin-4
Experimental: Cohort C
The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg
Drug: Victoza
doses of 1.8 mg
Other Names:
  • Liraglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK profile of acetaminophen
Time Frame: 13 weeks
Cmax, AUC at 13 weeks
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose metabolism
Time Frame: 13 weeks
Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks
13 weeks
Safety and tolerability
Time Frame: 18 weeks
Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Hanmi Clinical, California, United States

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-EXC-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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