Diabetes MellitusPhase 2NCT00701935

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

A Phase 2 study testing exenatide in people with Diabetes Mellitus, run by AstraZeneca at 17 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetes Mellitus
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: 80 participants
Where: 17 sitesin 2 countries
Study dates: Aug 2008to Jan 2012
Phase: Phase 2
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 and 85 years of age, inclusive.
Patients with type 2 diabetes
Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1
Patients have HbA1c of 7.0% to 8.9%, inclusive.
Patients have a body mass index >27 kg/m2 and <40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index >=25 kg/m2 is acceptable as the lower limit.
Patients have a history of stable body weight (not varying by >2 kg in the 3 months prior to Visit 1).
Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1.
Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.

Who cannot join

Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have a history of renal transplantation, or are currently receiving renal dialysis.
Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
Have known hemoglobinopathy or clinically significant, chronic anemia.
Known or are likely to become transfusion dependent during the study.

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Have active, symptomatic proliferative retinopathy.
Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics)
Have severe gastrointestinal disease, including gastroparesis.
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit 1.
Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded.
Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Acomplia [rimonabant]).
Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study.
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.
Are taking warfarin, or a coumarol derivative.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

Canada12 sites

Research Site
Brampton, Ontario
Research Site
Calgary, Alberta
Research Site
Chicoutimi, Quebec
Research Site
London, Ontario
Research Site
Ottawa, Ontario
Research Site
Pointe-Claire, Quebec
Research Site
Québec, Quebec
Research Site
Saint John, New Brunswick
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Research Site
Victoria, British Columbia
Research Site
Winnipeg, Manitoba

Other trials in Canada

United States5 sites

Research Site
Bellevue, Nebraska
Research Site
Colorado Springs, Colorado
Research Site
Honolulu, Hawaii
Research Site
Las Vegas, Nevada
Research Site
Temple, Arizona

Other trials in United States

About this study

Conditions: Diabetes Mellitus
Being tested: placebo, exenatide
Keywords: diabetes mellitus, Amylin, Lilly
Medical subject headings: 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, twice a day, 10mcg

Study groups in NCT00701935
Study group	Role	What they receive
1	Placebo comparator	Not described Receives: Drug: placebo
2	Experimental	Not described Receives: Drug: exenatide

What is being measured

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

Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Percentage change in abdominal visceral fat
Measured: baseline, 6 months

Secondary outcomes (12)

Percentage Change in Total Abdominal Fat From Baseline to 6 Months
Percentage change in total abdominal fat
Measured: baseline, 6 months
Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
Percentage change in subcutaneous abdominal fat
Measured: baseline, 6 months
Change in HbA1c From Baseline to 6 Months
Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Measured: baseline, 6 months
Percentage of Patients With HbA1c <=7.0% at 6 Months
Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Measured: 6 months
Change in Fasting Plasma Glucose From Baseline to 6 Months
Change in Fasting plasma glucose
Measured: baseline, 6 months
Change in Weight From Baseline to 6 Months
Change in weight
Measured: baseline, 6 months
Change in Systolic Blood Pressure From Baseline to 6 Months
Change in Systolic blood pressure
Measured: baseline, 6 months
Change in Diastolic Blood Pressure From Baseline to 6 Months
Change in Diastolic blood pressure
Measured: baseline, 6 months
Change in Total Cholesterol From Baseline to 6 Months
Change in total cholesterol
Measured: baseline, 6 months
Change in Triglycerides From Baseline to 6 Months
Change in triglycerides
Measured: baseline, 6 months
Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
Change in HDL cholesterol
Measured: baseline, 6 months
Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).
Measured: baseline, 6 months

Timeline

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

Aug 2008Jan 2012

First posted19 Jun 2008 (estimated)
Study startAug 2008
Primary completionJan 2012
Study completionJan 2012

Why it stopped: Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.

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 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00701935
Sponsor's protocol ID: H8O-CA-GWCE
Status last verified: Mar 2015
First submitted: 17 Jun 2008
Last updated: 10 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
ClinicalTrials.gov ID: NCT00701935
Acronym / sponsor ID: H8O-CA-GWCE
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus, Amylin, Lilly
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.
Enrolment: 80 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Aug 2008
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 19 Jun 2008 (estimated)
Results: Posted 13 Feb 2013

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: 2

Arm	Type	Receives
1	Placebo comparator	Drug: placebo
2	Experimental	Drug: exenatide

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients between 18 and 85 years of age, inclusive.
Patients with type 2 diabetes
Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1
Patients have HbA1c of 7.0% to 8.9%, inclusive.
Patients have a body mass index >27 kg/m2 and <40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index >=25 kg/m2 is acceptable as the lower limit.

Key exclusion criteria (15 listed)

Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have a history of renal transplantation, or are currently receiving renal dialysis.
Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
Have known hemoglobinopathy or clinically significant, chronic anemia.

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	1
exenatidesubcutaneous injection, twice a day, 10mcg	Drug	2

Primary outcome

Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Time frame: baseline, 6 months
Percentage change in abdominal visceral fat

12 secondary outcomes

Percentage Change in Total Abdominal Fat From Baseline to 6 Months
Time frame: baseline, 6 months
Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
Time frame: baseline, 6 months
Change in HbA1c From Baseline to 6 Months
Time frame: baseline, 6 months
Percentage of Patients With HbA1c <=7.0% at 6 Months
Time frame: 6 months
Change in Fasting Plasma Glucose From Baseline to 6 Months
Time frame: baseline, 6 months
Change in Weight From Baseline to 6 Months
Time frame: baseline, 6 months
Change in Systolic Blood Pressure From Baseline to 6 Months
Time frame: baseline, 6 months
Change in Diastolic Blood Pressure From Baseline to 6 Months
Time frame: baseline, 6 months
Change in Total Cholesterol From Baseline to 6 Months
Time frame: baseline, 6 months
Change in Triglycerides From Baseline to 6 Months
Time frame: baseline, 6 months
Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
Time frame: baseline, 6 months
Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
Time frame: baseline, 6 months

Results and safety

Results posted to the registry on 13 Feb 2013, 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 BID	43	27
Placebo	37	26

Primary outcome: Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months

Time frame: baseline, 6 months. Least squares mean (Standard Error). Unit: % change

Measure	Exenatide BID n = 29	Placebo n = 27
Value	-5.28 (3.23)	-4.30 (3.53)

Exenatide BID vs Placebo: Mean Difference (Final Values): -0.98 (95% CI -9.92 to 7.95), p = 0.8252, ANCOVA

Population analysed: Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide BID	3 of 43 (7%)	38 of 43 (88.4%)	Not reported
Placebo	1 of 37 (2.7%)	25 of 37 (67.6%)	Not reported

Limitations and caveats (from the sponsor): The dropout rate in the study was higher than anticipated (of 80 patients randomized, only 53 completed Study Period II), and enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Recruiting
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Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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.

Chief Medical Officer, MD Eli Lilly and Company study director

Eli Lilly and Company

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exenatide in people with Diabetes Mellitus, run by AstraZeneca at 17 sites in 2 countries.

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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada, 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?

Yes. Results are posted in the registry (first posted 13 Feb 2013). 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?

Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months (time frame: baseline, 6 months). 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 NCT00701935.

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 10 Apr 2015.