Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

A Phase 3 study testing Exenatide in people with Type 2 Diabetes, run by AstraZeneca at 53 sites in 8 countries.

Completed

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

Trial summary

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or… Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 53 sitesin 8 countries
Study dates: 30 May 2008to 1 Apr 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 years
All sexes
No healthy volunteers
Child

Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria:

are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm
have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria
have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit
have fasting C-peptide >0.6 ng/mL
have HbA1c between 6.5% and 10.5%, inclusive.

Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:

diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history
fasting blood glucose 126 mg/dL (7.0 mmol/L)
random blood glucose 200 mg/dL (11.1 mmol/L)
two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).

Exclusion Criteria-patients will be excluded from the study if they meet any of the following criteria:

have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide
are unwilling or unable to inject the study medication
currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily
have used oral steroids within the last 60 days or more than 20 days use within the past year
have used any weight loss medication(s) within 30 days of screening
have used insulin for more than 10 weeks during the 3 months prior to screening
have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males) or >1.4 mg/dL (123.8 µmol/L) (females)
have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase >3.0 times the upper limit of normal (ULN).

Trial locations and contacts

53 sites in 8 countries.

Country

City, postcode or hospital

53 sites in 8 countries

United States31 sites

Research Site
Aurora, Colorado, 80045
Research Site
Birmingham, Alabama, 35233
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois, 60637
Research Site
Dallas, Texas, 75235
Research Site
Dalton, Georgia, 30721
Research Site
Dearborn, Michigan, 48124
Research Site
Greenville, North Carolina, 27834
Research Site
Indianapolis, Indiana, 46202
Research Site
Jamaica, New York, 11432
Research Site
Kansas City, Missouri, 64108
Research Site
Los Angeles, California, 90048
Research Site
Melbourne, Florida, 32901
Research Site
Memphis, Tennessee, 38401
Research Site
Miami, Florida, 33144
Research Site
Miami Lakes, Florida, 33014
Research Site
Montclair, California, 91763
Research Site
Oklahoma City, Oklahoma, 73104-5008
Research Site
Orlando, Florida, 32806
Research Site
Pensacola, Florida, 32504
Research Site
Raleigh, North Carolina, 27610
Research Site
Reno, Nevada, 89502
Research Site
Sacramento, California, 95819
Research Site
San Antonio, Texas, 78207
Research Site
San Diego, California, 92123
Research Site
Santa Ana, California, 92707
Research Site
Spokane, Washington, 99202
Research Site
St Louis, Missouri, 63104
Research Site
Tallahassee, Florida, 32308
Research Site
Tucson, Arizona, 85724
Research Site
Wichita, Kansas, 67226

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Mexico7 sites

Research Site
Aguascalientes, 20127
Research Site
Culiacán, 80200
Research Site
Guadalajara, 44650
Research Site
Monterrey, 64710
Research Site
San Juan del Río, 76800
Research Site
Tamaupilas, 87070
Research Site
Tampico, 89170

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South Africa4 sites

Research Site
Moloto South, 1022
Research Site
Paarl, 7626
Research Site
Pretoria, 0087
Research Site
Verulam, 4345

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Brazil3 sites

Research Site
Fortaleza, 60430-370
Research Site
Juiz de Fora, 36025-330
Research Site
Santo André, 09030-010

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India3 sites

Research Site
Ahmedabad, 380006
Research Site
Bangalore
Research Site
Pune

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Russia3 sites

Research Site
Moscow, 125373
Research Site
Tomsk, 634050
Research Site
Ufa, 450077

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Philippines1 site

Research Site
Quezon City, 1100

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South Korea1 site

Research Site
Seoul

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About this study

Official title: Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.

Conditions: Type 2 Diabetes
Being tested: Placebo, Exenatide
Keywords: diabetes, adolescents, exenatide, Astra Zeneca
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
Subcutaneous injection, twice a day
ExenatideDrug
Subcutaneous injection, 5 µg, twice a day
ExenatideDrug
Subcutaneous injection,10 µg, twice a day

Study groups in NCT00658021
Study group	Role	What they receive
Placebo	Placebo comparator	Subcutaneous injection, twice a day Receives: Drug: Placebo
Exenatide 5 µg	Experimental	Subcutaneous injection, twice a day Receives: Drug: Exenatide
Exenatide 10 µg	Experimental	Subcutaneous injection, twice a day Receives: Drug: Exenatide

What is being measured

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

Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Measured: Baseline (Day 1) and Week 28
Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period
Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).
Measured: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.

Secondary outcomes (7)

Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28
The percentage of participants achieving HbA1c goals of < 7%, <= 6.5%, and < 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder.
Measured: Weeks 0, 4, 12, 20 and 28
Adjusted Change From Baseline in Body Weight Through Week 28
Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Measured: Baseline (Day 1) up to Week 28
Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28
Change from baseline in FSG is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An analysis of covariance (ANCOVA) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Measured: Baseline (Day 1) and Week 28
Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28
Change from baseline in SMBG measurements are reported as adjusted LS mean values at Week 28. SMBG measurements were taken before (pre-prandial) and 2 hours after (post-prandial) the 2 main meals of the day on 3 separate days during the week before baseline (Day 1) and Week 28. Post-prandial excursions were calculated as the difference between the pre-prandial and post-prandial blood glucose concentrations (post-prandial - pre-prandial) and averaged (mean) over the 2 main meals over the 3 separate days in each period. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Measured: Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28
Adjusted Change From Baseline in Fasting Serum Insulin at Week 28
Change from baseline in fasting serum insulin is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Measured: Baseline (Day 1) and Week 28
Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28
Change from baseline in HOMA-B and HOMA-S are reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Measured: Baseline (Day 1) and Week 28
Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28
Participants were discontinued from the study due to failure to maintain glycemic control if either discontinuation reason on summary case report form was "Loss of glucose control" or AE with lower level Medical Dictionary for Regulatory Activities (MedDRA) term "Loss of control of blood sugar" or "Hyperglycaemia" leading to study drug discontinuation, using MedDRA Version 23.0.
Measured: Weeks 2, 4, 8, 12, 16, 20, 24 and 28

Timeline

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

30 May 20081 Apr 2020

First posted14 Apr 2008 (estimated)
Study start30 May 2008
Primary completion18 Apr 2019
Study completion1 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00658021
Sponsor's protocol ID: D5550C00002
Other IDs: H8O-MC-GWBQ
Status last verified: Oct 2020
First submitted: 8 Apr 2008
Last updated: 1 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment. https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
ClinicalTrials.gov ID: NCT00658021
Acronym / sponsor ID: D5550C00002
Conditions: Type 2 Diabetes
Keywords: diabetes, adolescents, exenatide, Astra Zeneca
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: 30 May 2008 (actual)
Primary completion: 18 Apr 2019 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 14 Apr 2008 (estimated)
Results: Posted 1 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboSubcutaneous injection, twice a day
Exenatide 5 µg	Experimental	Drug: ExenatideSubcutaneous injection, twice a day
Exenatide 10 µg	Experimental	Drug: ExenatideSubcutaneous injection, twice a day

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

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
PlaceboSubcutaneous injection, twice a day	Drug	Placebo
ExenatideSubcutaneous injection, 5 µg, twice a day	Drug	Exenatide 5 µg
ExenatideSubcutaneous injection,10 µg, twice a day	Drug	Exenatide 10 µg

Primary outcome

Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
Time frame: Baseline (Day 1) and Week 28
Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period
Time frame: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.
Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).

7 secondary outcomes

Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28
Time frame: Weeks 0, 4, 12, 20 and 28
Adjusted Change From Baseline in Body Weight Through Week 28
Time frame: Baseline (Day 1) up to Week 28
Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28
Time frame: Baseline (Day 1) and Week 28
Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28
Time frame: Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28
Adjusted Change From Baseline in Fasting Serum Insulin at Week 28
Time frame: Baseline (Day 1) and Week 28
Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28
Time frame: Baseline (Day 1) and Week 28
Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 28

Results and safety

Results posted to the registry on 1 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide 5 mcg	42	31
Exenatide 10 mcg	38	25
Placebo	42	25

Primary outcome: Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28

Time frame: Baseline (Day 1) and Week 28. Least squares mean (Standard Error). Unit: percentage (%HbA1c)

Measure	Total Exenatide Twice Daily (EBID) n = 78	Placebo n = 42
Value	0.11 (0.215)	0.38 (0.293)

Total Exenatide Twice Daily (EBID) vs Placebo: LS Mean Difference: -0.28 (95% CI -1.01 to 0.45), p = 0.444, Mixed Models Analysis

Population analysed: The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.

Primary outcome: Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period

Time frame: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.. Count of participants. Unit: Participants

Measure	Exenatide 5 mcg n = 7	Exenatide 10 mcg n = 5	Placebo n = 7
Value	0	0	0

Population analysed: The Safety Follow-up Analysis Set included all participants who had at least 1 safety follow-up period assessment visit.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious AEs: From first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 32 weeks. Non-serious AEs: From first dose of study drug (Day 1) up to 1 day after last dose of study drug, approximately 28 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide 5 mcg	3 of 41 (7.3%)	26 of 41 (63.4%)	0 of 41
Exenatide 10 mcg	1 of 37 (2.7%)	24 of 37 (64.9%)	0 of 37
Placebo	1 of 42 (2.4%)	23 of 42 (54.8%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical\_Study\_Protocol\_redactedLink provided by the sponsor.
Statistical Analysis Plan\_redactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment. https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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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.

53 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide in people with Type 2 Diabetes, run by AstraZeneca at 53 sites in 8 countries.

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

Who may be eligible to take part?

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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Mexico, South Africa, Brazil, India and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28 (time frame: Baseline (Day 1) and Week 28). The study lists 2 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 NCT00658021.

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 1 Dec 2020.