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Completed

NCT Number: NCT02057172

Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of 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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hanmi pharmaceutical

CA, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM11260C

Drug

HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)

Other names: LAPS-Exendin-4

liraglutide

Drug

Liraglutide is a GLP-1 agonist.

Other names: Victoza

Placebo

Drug

Placebo

Primary outcomes

  1. Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks

    Time frame: Up to 127 days

Secondary outcomes

  1. Fasting plasma glucose levels (FPG)

    Time frame: Up to 127 days

  2. 7-point glucose profile

    Time frame: Up to day 127

  3. Other glycaemic control parameters

    Time frame: Up to day 127

  4. Serum lipid profile

    Time frame: Up to day 127

  5. Body weight

    Time frame: Up to day 127

  6. Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%

    Time frame: Up to 127 days

Other outcomes

  1. Assess the safety and tolerability of HM11260C

    Time frame: Up to day 127

  2. Assess the immunogenicity of HM11260C

    Time frame: Up to day 127

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2014
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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