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Trial · Interventional

Status unknownPhase 1Registry data

A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Overview

Status
Status unknown
Phase
Phase 1
Enrollment
44 participants (estimated)
Sponsor
Hanmi Pharmaceutical Company Limited · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Dec 2013
Primary completion
Oct 2014 (estimated)
Completion
Dec 2014 (estimated)
First posted
11 Feb 2014 (estimated)
Last update posted
11 Feb 2014 (estimated)
Conditions
Diabetes Mellitus

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

    A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

    NCT02059564

    Dec 2013 to est. Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • HM11260CDrug
  • PlaceboDrug
  • VictozaDrug

Arms3

  • Experimental

    Cohort A

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

  • Experimental

    Cohort B

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

  • Experimental

    Cohort C

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. PK profile of acetaminophen

    Time frame · 13 weeks

    Registry description

    Cmax, AUC at 13 weeks

Secondary outcomes(2)
  1. Glucose metabolism

    Time frame · 13 weeks

    Registry description

    Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks

  2. Safety and tolerability

    Time frame · 18 weeks

    Registry description

    Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

8 results

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.

Hompesch et al. 2021BMJ open diabetes research & carecited by 14

PMID 34172436PMC8237726DOI 10.1136/bmjdrc-2021-002208PUB-34172436

Free to read · publisher termsCC BY-NC8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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