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

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057172
• Other study ID #: HM-EXC-203
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2014
• Last updated: August 8, 2016
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
• liraglutide
Liraglutide is a GLP-1 agonist.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Hanmi pharmaceutical	CA	California

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess the safety and tolerability of HM11260C		Up to day 127	Yes
Other	Assess the immunogenicity of HM11260C		Up to day 127	Yes
Primary	Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks		Up to 127 days	No
Secondary	Fasting plasma glucose levels (FPG)		Up to 127 days	No
Secondary	7-point glucose profile		Up to day 127	Yes
Secondary	Other glycaemic control parameters		Up to day 127	Yes
Secondary	Serum lipid profile		Up to day 127	No
Secondary	Body weight		Up to day 127	No
Secondary	Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%		Up to 127 days	No