NCT02059564

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

February 5, 2014

Last Update Submit

February 7, 2014

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesExendin-4

Outcome Measures

Primary Outcomes (1)

  • PK profile of acetaminophen

    Cmax, AUC at 13 weeks

    13 weeks

Secondary Outcomes (2)

  • Glucose metabolism

    13 weeks

  • Safety and tolerability

    18 weeks

Study Arms (3)

Cohort A

EXPERIMENTAL

The weekly treatment of the 6 mg HM11260C or placebo will be maintained

Drug: HM11260CDrug: Placebo

Cohort B

EXPERIMENTAL

The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg

Drug: HM11260CDrug: Placebo

Cohort C

EXPERIMENTAL

The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg

Drug: Victoza

Interventions

HM11260CDRUG

doses of 6 mg, 16 mg

Also known as: LAPS-Exendin-4
Cohort ACohort B
PlaceboDRUG

Normal saline solution

Also known as: Normal saline solution
Cohort ACohort B
VictozaDRUG

doses of 1.8 mg

Also known as: Liraglutide
Cohort C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi

California City, California, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34172436DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Interventions

Saline SolutionLiraglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsGlucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Hanmi Clinical

    California, United States

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanmi Clinical

CONTACT

clinical4@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 11, 2014

Study Start

December 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

US(1)