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Trial · Interventional

CompletedPhase 2Registry data

Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

NCTNCT02057172 (opens ClinicalTrials.gov in a new tab)Other idHM-EXC-203
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
254 participants (actual)
Sponsor
Hanmi Pharmaceutical Company Limited · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jan 2014
Primary completion
Oct 2014
Completion
Dec 2014
First posted
6 Feb 2014 (estimated)
Last update posted
9 Aug 2016 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 2

    Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

    NCT02057172

    Jan 2014 to Dec 2014

Registry summary

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

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).

Interventions

  • HM11260CDrug
  • liraglutideDrug
  • PlaceboDrug

Arms7

  • Experimental

    HM11260C (0.3 mg)

    Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks

  • Experimental

    HM11260C (1 mg)

    Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks

  • Experimental

    HM11260C (2 mg)

    Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks

  • Experimental

    HM11260C (3 mg)

    Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks

  • Experimental

    HM11260C (4 mg)

    Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks

  • Placebo comparator

    Placebo

    Weekly administration of placebo by subcutaneous injection for 12 weeks

  • Active comparator

    Liraglutide

    Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks

    Time frame · Up to 127 days

Secondary outcomes(6)

  1. Fasting plasma glucose levels (FPG)

    Time frame · Up to 127 days

  2. 7-point glucose profile

    Time frame · Up to day 127

  3. Other glycaemic control parameters

    Time frame · Up to day 127

  4. Serum lipid profile

    Time frame · Up to day 127

  5. Body weight

    Time frame · Up to day 127

  6. Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%

    Time frame · Up to 127 days

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.

Completed trials do not always post results.

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 · 2019

8 results

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.

Rosenstock et al. 2019Diabetes carecited by 32

PMID 31320446DOI 10.2337/dc18-2648PUB-31320446

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 74 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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