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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT02081118 (opens ClinicalTrials.gov in a new tab)Other idHM-EXC-204
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Feb 2014
Primary completion
Mar 2015
Completion
Apr 2015
First posted
7 Mar 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
201420152016
  1. Ph 2

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

    NCT02081118

    Feb 2014 to Apr 2015

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 month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).

Interventions

  • HM11260CDrug
  • PlaceboDrug

Arms4

  • Experimental

    HM11260C (8 mg)

    Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks

  • Experimental

    HM11260C (12 mg)

    Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks

  • Experimental

    HM11260C (16 mg)

    Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks

  • Placebo comparator

    Placebo

    Monthly administration of placebo by subcutaneous injection for 16 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks

    Time frame · Up to day 155

Secondary outcomes(8)

  1. Fasting plasma glucose levels (FPG)

    Time frame · Up to day 155

  2. 7-point glucose profile

    Time frame · Up to day 155

  3. Serum lipid profile

    Time frame · Up to day 155

  4. Body weight

    Time frame · Up to day 155

  5. Fasting insulin

    Time frame · Up to day 155

  6. C-peptide

    Time frame · Up to day 155

  7. Glucagon

    Time frame · Up to day 155

  8. Glycated albumin

    Time frame · Up to day 155

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

Studies0

Studies that cite this trial.

No study cites this trial.

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 * Taking a stable dose of 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 at screening * 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 acute or chronic pancreatitis * A history of alcohol or drug abuse or drug addiction

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