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Type 2 Diabetes MellitusPhase 2NCT00103935

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

A Phase 2 study testing Exenatide LAR in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Exenatide LAR
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
7 sitesUnited States
Study dates
Feb 2005to Oct 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Research Site

    Butte, Montana

  • Research Site

    Honolulu, Hawaii

  • Research Site

    Olympia, Washington

  • Research Site

    Portland, Oregon

  • Research Site

    San Antonio, Texas

  • Research Site

    St Louis, Missouri

  • Research Site

    Walnut Creek, California

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects With Type 2 Diabetes Mellitus

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.

Being tested
placebo, Exenatide LAR
Keywords
diabetes, exenatide, long acting release, Amylin, Lilly
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg

  • placeboDrug

    Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg

  • Exenatide LARDrug

    Also called Bydureon

    Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.

  • Exenatide LARDrug

    Also called Bydureon

    Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.

Study groups in NCT00103935
Study groupRoleWhat they receive
Group A1Placebo comparatorPlacebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
Receives: Drug: placebo
Group A2Placebo comparatorPlacebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
Receives: Drug: placebo
Group BExperimentalExenatide lead-in followed by exenatide LAR 0.8 mg weekly
Receives: Drug: Exenatide LAR
Group CExperimentalExenatide lead-in followed by exenatide LAR 2.0 mg weekly
Receives: Drug: Exenatide LAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: 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).

    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.

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

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

    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

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

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

    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

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

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

    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])

    Measured: Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionOct 2005
  4. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103935
Sponsor's protocol ID
2993LAR-104
Status last verified
Jan 2015
First submitted
17 Feb 2005
Last updated
24 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Fineman M, Flanagan S, Taylor K, Aisporna M, Shen LZ, Mace KF, Walsh B, Diamant M, Cirincione B, Kothare P, Li WI, MacConell L. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011 Jan;50(1):65-74. doi: 10.2165/11585880-000000000-00000.

    PubMed 21142268

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exenatide LAR in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00103935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015; AzTrials last refreshed its copy on 2 Nov 2026.

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