Type 2 Diabetes MellitusPhase 2NCT00254254
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
A Phase 2 study of Type 2 Diabetes Mellitus, run by AstraZeneca at 5 sites in United States.
Trial summary
This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2006to Feb 2007
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
- Has HbA1c 6.0% to 11.0%, inclusive, at screening.
- Has a body weight of >= 50 kg at screening.
Who cannot join
- Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
- Currently participates in any other interventional study.
- Is currently treated with any of the following excluded medications:
- Sulfonylurea chlorpropamide
- Thiazolidinedione within 3 months of screening.
- Αlpha glucosidase inhibitor within 3 months of screening.
Show all 9Show fewer
- Meglitinide within 3 months of screening.
- Insulin within 3 months of screening.
- Pramlintide within 3 months of screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Denver, Colorado
Research Site
Little Rock, Arkansas
Research Site
Louisville, Kentucky
Research Site
San Antonio, Texas
Research Site
San Diego, California
About this study
Official title: A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Exenatide - Exenatide - Placebo, Exenatide - Placebo - Exenatide, Placebo - Exenatide - Exenatide
- Keywords
- diabetes, adolescents, exenatide, 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.
Exenatide - Exenatide - PlaceboDrug
Also called Byetta
Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections.
Exenatide - Placebo - ExenatideDrug
Also called Byetta
Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
Placebo - Exenatide - ExenatideDrug
Also called Byetta
Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL Receives: Drug: Exenatide - Exenatide - Placebo |
| Sequence 2 | Experimental | Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg Receives: Drug: Exenatide - Placebo - Exenatide |
| Sequence 3 | Experimental | Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg Receives: Drug: Placebo - Exenatide - Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pharmacokinetics of exenatide
To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve.
Measured: Three day-long (8 hour) assessments over a 5-week period
To assess the pharmacodynamics of exenatide
To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration.
Measured: Three day-long (8 hour) assessments over a 5-week period
Number of adverse events
Adverse events will be assessed at all visits after the Screening Visit [Visit 2 (first time subject is dosed) through Visit 4 (study termination)]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values
Measured: Visit 2 through Visit 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startFeb 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Lisa Porter, MD, Study director, Amylin Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254254
- Sponsor's protocol ID
- 2993-124
- Status last verified
- Jan 2015
- First submitted
- 14 Nov 2005
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.
PubMed 19446153
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00254254
- Acronym / sponsor ID
- 2993-124
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, adolescents, exenatide, Amylin, Lilly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 16 Nov 2005 (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 study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Exenatide - Exenatide - PlaceboExenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL |
| Sequence 2 | Experimental | Drug: Exenatide - Placebo - ExenatideExenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg |
| Sequence 3 | Experimental | Drug: Placebo - Exenatide - ExenatidePlacebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
- Has HbA1c 6.0% to 11.0%, inclusive, at screening.
- Has a body weight of >= 50 kg at screening.
Key exclusion criteria (9 listed)
- Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
- Currently participates in any other interventional study.
- Is currently treated with any of the following excluded medications:
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 |
|---|---|---|
| Exenatide - Exenatide - PlaceboAlso: ByettaExenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections. | Drug | Sequence 1 |
| Exenatide - Placebo - ExenatideAlso: ByettaExenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections. | Drug | Sequence 2 |
| Placebo - Exenatide - ExenatideAlso: ByettaPlacebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections. | Drug | Sequence 3 |
Primary outcome
To assess the pharmacokinetics of exenatide
Time frame: Three day-long (8 hour) assessments over a 5-week period
To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve.
To assess the pharmacodynamics of exenatide
Time frame: Three day-long (8 hour) assessments over a 5-week period
To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration.
Number of adverse events
Time frame: Visit 2 through Visit 4
Adverse events will be assessed at all visits after the Screening Visit [Visit 2 (first time subject is dosed) through Visit 4 (study termination)]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values
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 23 Feb 2015.
- Derived from this study: PubMed 19446153Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.
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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.
Lisa Porter, MD study director
Amylin Pharmaceuticals, LLC.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type 2 Diabetes Mellitus, run by AstraZeneca at 5 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 9 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 23 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 5 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. 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 assess the pharmacokinetics of exenatide (time frame: Three day-long (8 hour) assessments over a 5-week period). The study lists 3 primary outcomes in all. 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 NCT00254254, 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 23 Feb 2015.