Skip to main content
OpenTrials
Completed

NCT Number: NCT02081118

Glycaemic Control of Monthly 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 month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).

Completed

Looking for future studies?

Notify Me

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

Miami, Florida, 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
  • Taking a stable dose of 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 at screening
  • 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 acute or 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

Placebo

Drug

Placebo for HM11260C

Primary outcomes

  1. Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks

    Time frame: Up to day 155

Secondary outcomes

  1. Fasting plasma glucose levels (FPG)

    Time frame: Up to day 155

  2. 7-point glucose profile

    Time frame: Up to day 155

  3. Serum lipid profile

    Time frame: Up to day 155

  4. Body weight

    Time frame: Up to day 155

  5. Fasting insulin

    Time frame: Up to day 155

  6. C-peptide

    Time frame: Up to day 155

  7. Glucagon

    Time frame: Up to day 155

  8. Glycated albumin

    Time frame: Up to day 155

Other outcomes

  1. Number of Participants with Adverse Events by HM11260C

    Time frame: Up to day 155

  2. Number of Participants with Immunogenicity by HM11260C

    Time frame: Up to day 155

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.