Diabetes Mellitus, Non-Insulin-DependentPhase 2NCT00044707
Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
A Phase 2 study testing Pramlintide acetate in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 1 site in United States.
Trial summary
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Pramlintide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Sep 2002
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes mellitus treated with diet and/or oral agents
- HbA1c 6.5-11.0
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICSL-Clinical Studies
Fort Lauderdale, Florida, 33301
About this study
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Pramlintide acetate
- Keywords
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramlintide acetateDrug
Clear, colorless, sterile solution for SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Pramlintide acetate (AC137) | Active comparator | Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL Receives: Drug: Pramlintide acetate |
| Placebo | Placebo comparator | Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of pramlintide on the PK of an oral medication
To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax.
t½: Terminal half-life
The primary study endpoints include:
- pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints
- pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations
Measured: 7 Days
Secondary outcomes (1)
safety and tolerability as measured by analysis of laboratory values and adverse events
To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen).
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2002 (estimated)
- Study startAug 2002
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044707
- Sponsor's protocol ID
- 137-154
- Status last verified
- May 2015
- First submitted
- 3 Sep 2002
- Last updated
- 21 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
- ClinicalTrials.gov ID
- NCT00044707
- Acronym / sponsor ID
- 137-154
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 5 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramlintide acetate (AC137) | Active comparator | Drug: Pramlintide acetatePramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL |
| Placebo | Placebo comparator | –Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus treated with diet and/or oral agents
- HbA1c 6.5-11.0
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramlintide acetateClear, colorless, sterile solution for SC injection. | Drug | Pramlintide acetate (AC137) |
Primary outcome
To determine the effect of pramlintide on the PK of an oral medication
Time frame: 7 Days
To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax. t½: Terminal half-life The primary study endpoints include: * pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints * pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations
1 secondary outcome
safety and tolerability as measured by analysis of laboratory values and adverse events
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pramlintide acetate in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 1 site 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 2 inclusion and 0 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine the effect of pramlintide on the PK of an oral medication (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2015.