Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

August 8, 2016 updated by: Hanmi Pharmaceutical Company Limited

A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes

The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 2

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
      • CA, California, United States
        • Hanmi pharmaceutical

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 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages eligible for study : 18 years to 74 years
  • Genders eligible for study : Male and Female
  • Diagnosed with T2DM
  • Received diet and exercise therapy with or without metformin monotherapy
  • HbA1c levels of between ≥ 7.0% and ≤ 10.0%
  • Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
  • Written informed consent must be obtained

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Diagnosis of type 1 diabetes mellitus
  • Uncontrolled diabetes defined as a FPG level of > 240 mg/dL
  • A significant change in body weight in the 3 months before screening
  • Any history of GI intolerance
  • Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
  • Known history of chronic pancreatitis
  • A history of alcohol or drug abuse or drug addiction

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HM11260C (0.3 mg)
Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks
Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Names:
  • LAPS-Exendin-4
Experimental: HM11260C (1 mg)
Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks
Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Names:
  • LAPS-Exendin-4
Experimental: HM11260C (2 mg)
Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks
Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Names:
  • LAPS-Exendin-4
Experimental: HM11260C (3 mg)
Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks
Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Names:
  • LAPS-Exendin-4
Experimental: HM11260C (4 mg)
Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks
Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Names:
  • LAPS-Exendin-4
Placebo Comparator: Placebo
Weekly administration of placebo by subcutaneous injection for 12 weeks
Drug: Placebo
Placebo
Active Comparator: Liraglutide
Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.
Drug: liraglutide
Liraglutide is a GLP-1 agonist.
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks
Time Frame: Up to 127 days
Up to 127 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose levels (FPG)
Time Frame: Up to 127 days
Up to 127 days
7-point glucose profile
Time Frame: Up to day 127
Up to day 127
Other glycaemic control parameters
Time Frame: Up to day 127
Up to day 127
Serum lipid profile
Time Frame: Up to day 127
Up to day 127
Body weight
Time Frame: Up to day 127
Up to day 127
Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%
Time Frame: Up to 127 days
Up to 127 days

Other Outcome Measures

Outcome Measure
Time Frame
Assess the safety and tolerability of HM11260C
Time Frame: Up to day 127
Up to day 127
Assess the immunogenicity of HM11260C
Time Frame: Up to day 127
Up to day 127

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Study Director: Hanmi Pharmaceutical, clinical4@hanmi.co.kr

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

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 6, 2014

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-EXC-203

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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