GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With Thiazolidinedione Alone or Thiazolidinedione in Combination With Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

134

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-10%

Primary endpoints

•Treatment-emergent AEs (any)•Documented hypoglycemia

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00753896

Org study IDH8O-MC-GWDC

Timeline

Milestones

Study first posted2008-09-17estimated

Results first posted2012-03-20estimated

Last update posted2015-04-21estimated

Study start2008-10 (month precision)

Primary completion2009-07actual (month precision)

Study completion2009-11actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes

•At least 18 years of age at screening.

•Have HbA1c of 7.1% to 10.0%, inclusive, at screening.

•Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

•Have been treated with a stable dose of TZD (≥4 mg/day rosiglitazone or ≥30 mg/day pioglitazone) for at least 120 days prior to Visit 1 OR Have been treated with a stable dose of TZD (≥4 mg/day rosiglitazone or ≥30 mg/day pioglitazone) for at least 120 days PLUS a stable dose of metformin for at least 90 days prior to Visit 1.

•Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).

•If female of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.

–Are not breastfeeding.

–Test negative for pregnancy at the time of screening based on a serum pregnancy test.

–Intend not to become pregnant during the study.

–Have practiced a reliable method of birth control (e.g., use of oral contraceptives or approved hormonal implant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening.

–Agree to continue to use a reliable method of birth control (see above) during the study.

Exclusion criteria

•Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, angioplasty.

•Is expected to require coronary artery bypass surgery or angioplasty during the course of the study.

•Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis

•Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine ≥135 μmol/L for males and ≥110 μmol/L for females.

•Have 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 known hemoglobinopathy or chronic anemia (hemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females).

•Have clinically significant history or presence of severe gastrointestinal disease, particularly those which may impact gastric emptying, such as gastroparesis, pyloric stenosis, or gastric bypass surgery.

•Have a history of pancreatitis.

•Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.

•Have any contraindication for the OAD(s) which they use, according to local label requirements.

•Are known to have active proliferative retinopathy.

•Are receiving chronic (>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received systemic glucocorticoid therapy for >2 weeks within the 4 weeks immediately preceding screening.

•Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.

•Have previously been treated with glucagon-like peptide 1 analogs or liraglutide.

•Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: Insulin; Sulfonylureas; Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose]); Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]); Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin]); Symlin® (pramlintide acetate).

•Have had an organ transplant.

•Have donated blood within 30 days of screening.

•Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

•Are currently participating in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment is given). Patients completing the final visit of a study examining safety/efficacy of exenatide BID may enter this study on the same day if they meet other eligibility criteria.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 52

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Exenatide Once Weekly	-1.50	—

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change in HbA1c From Baseline to Week 52

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of total hemoglobin	95% CI
Exenatide Once Weekly	-0.78	—

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=7% at Week 52

Time frame:Baseline, Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide Once Weekly	68.8	—

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=6.5% at Week 52

Time frame:Baseline, Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide Once Weekly	54.2	—

Secondary/protocol endpoint

Change in Fasting Serum Glucose From Baseline to Week 52

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Exenatide Once Weekly	-1.59	—

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 52

Time frame:Baseline, Week 52

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mmol/L	95% CI
Exenatide Once Weekly	-0.18	—

Secondary/protocol endpoint

Change in High-density Lipoprotein (HDL) From Baseline to Week 52

Time frame:Baseline, Week 52

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mmol/L	95% CI
Exenatide Once Weekly	0.04	—

Secondary/protocol endpoint

Change in Triglycerides From Baseline to Week 52

Time frame:Baseline, Week 52

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mmol/L	95% CI
Exenatide Once Weekly	-0.19	—

Secondary/protocol endpoint

Change in Blood Pressure From Baseline to Week 52

Time frame:Baseline, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Once WeeklySystolic Blood Pressure	-1.69	—
Diastolic Blood Pressure	-0.19	—

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Percentage of Patients Experiencing Adverse Events

Time frame:Baseline to Week 52

Treatment-emergent AEs (any)

descriptive

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide Once Weekly	73.1	—

Primary/protocol endpoint

Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events

Time frame:Baseline to Week 52

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exenatide Once WeeklyMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.02	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Safety of exenatide once weekly in patients with type 2 diabetes mellitus treated with a thiazolidinedione alone or in combination with metformin for 2 years.
Clinical therapeutics2012 Oct (month)PMID23031623doi:10.1016/j.clinthera.2012.09.007via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.