Skip to content

Trial · Interventional

CompletedPhase 2Registry data

Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

NCTNCT00103935 (opens ClinicalTrials.gov in a new tab)Other id2993LAR-104
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
45 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Feb 2005
Primary completion
Oct 2005
Completion
Oct 2005
First posted
18 Feb 2005 (estimated)
Last update posted
24 Feb 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006
  1. Ph 2

    Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

    NCT00103935

    Feb 2005 to Oct 2005

Registry summary

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

Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

Interventions

  • placeboDrug
  • placeboDrug
  • Exenatide LARDrug
  • Exenatide LARDrug

Arms4

  • Placebo comparator

    Group A1

    Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR

  • Placebo comparator

    Group A2

    Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR

  • Experimental

    Group B

    Exenatide lead-in followed by exenatide LAR 0.8 mg weekly

  • Experimental

    Group C

    Exenatide lead-in followed by exenatide LAR 2.0 mg weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)

    Time frame · Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours

Secondary outcomes(5)

  1. Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus

    Time frame · Various time intervals from Day 1 to Week 15

  2. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).

    Time frame · Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

    Registry description

    Change in HbA1c from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination.

  3. Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)

    Time frame · Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

    Registry description

    Change in fasting glucose concentrations from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination

  4. Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)

    Time frame · Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

    Registry description

    Change in body weight (kg) from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination

  5. Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15

    Time frame · Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15

    Registry description

    Change in seven-point glucose concentrations from baseline (collected on 3 days between Visit 2 \[Day -7\] and Visit 3 \[Day -3\]) to Visit 25 (collected on 3 days between Visit 20 \[Week 14\] and Visit 25 \[Week 15\])

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

PubMed tag: none · 2011

12 results

Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing.

Fineman et al. 2011Clinical pharmacokineticscited by 116

PMID 21142268DOI 10.2165/11585880-000000000-00000PUB-21142268

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months. * Has HbA1c of 7.1% to 11.0%, inclusive. * Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. Exclusion Criteria: * Received any investigational drug within 3 months prior to screening. * Is currently treated with any of the following excluded medications: \*Thiazolidinediones within 3 months of screening; \* Sulfonylureas within 3 months of screening; \* Insulin within 1 year of screening. * Participated previously in an exenatide clinical study.

PepBank is a research reference. Talk to a doctor before you use any peptide.