Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
NCT ID: NCT02057172
Last Updated: 2016-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2014-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HM11260C (0.3 mg)
Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks
HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
HM11260C (1 mg)
Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks
HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
HM11260C (2 mg)
Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks
HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
HM11260C (3 mg)
Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks
HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
HM11260C (4 mg)
Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks
HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Placebo
Weekly administration of placebo by subcutaneous injection for 12 weeks
Placebo
Placebo
Liraglutide
Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.
liraglutide
Liraglutide is a GLP-1 agonist.
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Hanmi pharmaceutical
CA, California, United States
Countries
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References
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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.
Other Identifiers
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HM-EXC-203
Identifier Type: -
Identifier Source: org_study_id
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