Clinical trial NCT02057172: Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: glycaemic control
HM11260C
placebo
safety
tolerability
type 2 diabetes mellitus
efficacy
T2DM
glycated haemoglobin (HbA1c)
glycosylated haemoglobin (HbA1c)
Glucagon-Like Peptide-1 (GLP-1) agonists
blood sugar levels
fasting plasma glucose (FPG)
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-02-06
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks
timeFrame: Up to 127 days
Secondary outcomes:
measure: Fasting plasma glucose levels (FPG)
timeFrame: Up to 127 days
measure: 7-point glucose profile
timeFrame: Up to day 127
measure: Other glycaemic control parameters
timeFrame: Up to day 127
measure: Serum lipid profile
timeFrame: Up to day 127
measure: Body weight
timeFrame: Up to day 127
measure: Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%
timeFrame: Up to 127 days
Other outcomes:
measure: Assess the safety and tolerability of HM11260C
timeFrame: Up to day 127
measure: Assess the immunogenicity of HM11260C
timeFrame: Up to day 127
Locations:
city: CA
country: United States
facility: Hanmi pharmaceutical
state: California
Study officials:
affiliation: clinical4@hanmi.co.kr
name: Hanmi Pharmaceutical
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH. Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide. Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18.