Clinical trial NCT02059564: A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Official title: A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exendin-4
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus

Detailed description: Primary Objective

- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying

Secondary Objectives

* evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test
* evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide
* evaluate safety and tolerability of different doses of HM11260C and liraglutide
* evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
* History of type 2 diabetes
* Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
* Use of approved methods of contraception
* Ability to provide written informed consent

Exclusion Criteria:

* Type 1 diabetes
* Significant acute diabetic proliferative retinopathy or severe neuropathy
* Systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg at screening
* Pregnant or lactating women
* Participation in an investigational study within 30 days prior to randomization
* History of any major surgery within 6 months prior to Screening
* History of any serious adverse reaction or hypersensitivity to any of the product components.
* History of renal disease or significantly abnormal kidney function tests at Screening
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 30 days prior to Randomization
* Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
* Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
* Donation or loss of \>500 mL of blood or blood product within 56 days of Randomization

Primary outcomes:
measure: PK profile of acetaminophen
timeFrame: 13 weeks
Secondary outcomes:
measure: Glucose metabolism
timeFrame: 13 weeks
measure: Safety and tolerability
timeFrame: 18 weeks
Other outcomes:
Locations:
city: California
country: United States
facility: Hanmi
state: California
Study officials:
affiliation: California, United States
name: Hanmi Clinical
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hompesch M, Kang J, Han O, Trautmann ME, Sorli CH, Ogbaa I, Stewart J, Morrow L. Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002208. doi: 10.1136/bmjdrc-2021-002208.