GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

261

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.1-10.5%

Primary endpoint

•HbA1c, change

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 IDNCT00765817

Org study IDH8O-US-GWCO

Timeline

Milestones

Study first posted2008-10-03estimated

Results first posted2011-01-26estimated

Last update posted2016-10-24estimated

Study start2008-10 (month precision)

Primary completion2010-01actual (month precision)

Study completion2010-01actual (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.

•Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

1. metformin (stable dose for 6 weeks)

2. pioglitazone (stable dose for 6 weeks)

3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

–Have HbA1C between 7.1% and 10.5%, inclusive.

–Have a body mass index (BMI) ≤45 kg/m2.

–Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion criteria

•Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.

•Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.

•Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.

•Women who are breastfeeding.

•Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.

•Have had a kidney transplant or are currently on kidney dialysis.

•Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.

•Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.

•Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.

•Are currently on a weight-loss program or have been on one within 3 months of entering the study.

•Have had a blood transfusion or severe blood loss within 3 months of entering the study.

•Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.

•Have an irregular sleep cycle (for example, sleeping during the day and working during the night).

•Have a history of pancreatitis.

•Have received treatment with an experimental drug within 30 days of entering the study.

•If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.

•If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.

•If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Endpoints (17)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline and 30 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Arm	-1.78	—
Placebo Arm	0.96	—

p<0.001ANCOVA

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:baseline and 30 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Exenatide Arm	-1.08	—
Placebo Arm	-0.25	—

p0.226ANCOVA

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c)

Time frame:baseline and 30 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of hemoglobin	95% CI
Exenatide Arm	-1.71	—
Placebo Arm	-1.00	—

p<0.001ANCOVA

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=7%

Time frame:baseline and 30 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage	95% CI
Exenatide Arm	58.3	—
Placebo Arm	31.1	—

p<0.001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=6.5%

Time frame:baseline and 30 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage	95% CI
Exenatide Arm	42.0	—
Placebo Arm	13.3	—

p<0.001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Fasting Serum Glucose

Time frame:baseline and 30 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Arm	-1.28	—
Placebo Arm	-0.87	—

p0.174ANCOVA

Secondary/protocol endpoint

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

Time frame:baseline and 30 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide ArmPre-breakfast: baseline	7.89	—
Pre-breakfast: change at week 30	-1.58	—
2 hour post-breakfast: baseline	10.89	—
2 hour post-breakfast: change at week 30	-3.56	—
Pre-lunch: baseline	8.95	—
Pre-lunch: change at week 30	-2.23	—
2 hour post-lunch: baseline	11.35	—
2 hour post-lunch: change at week 30	-2.74	—
Pre-dinner: baseline	9.85	—
Pre-dinner: change at week 30	-2.25	—
2 hour post-dinner: baseline	12.03	—
2 hour post-dinner: change at week 30	-3.87	—
0300: baseline	8.95	—
0300: change at week 30	-2.27	—
Placebo ArmPre-breakfast: baseline	8.27	—
Pre-breakfast: change at week 30	-1.48	—
2 hour post-breakfast: baseline	11.82	—
2 hour post-breakfast: change at week 30	-1.72	—
Pre-lunch: baseline	9.77	—
Pre-lunch: change at week 30	-1.15	—
2 hour post-lunch: baseline	11.70	—
2 hour post-lunch: change at week 30	-1.38	—
Pre-dinner: baseline	9.99	—
Pre-dinner: change at week 30	-1.33	—
2 hour post-dinner: baseline	11.86	—
2 hour post-dinner: change at week 30	-1.34	—
0300: baseline	9.20	—
0300: change at week 30	-1.48	—

Secondary/protocol endpoint

Change in Daily Insulin Dose

Time frame:baseline and 30 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), insulin units (U)	95% CI
Exenatide Arm	13.19	—
Placebo Arm	19.71	—

p0.026ANCOVA

Secondary/protocol endpoint

Change in Daily Insulin Dose (on a Per Body Weight Basis)

Time frame:baseline and 30 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), insulin units per kg (U/kg)	95% CI
Exenatide Arm	0.15	—
Placebo Arm	0.20	—

p0.070ANCOVA

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:baseline and 30 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Arm	-0.16	—
Placebo Arm	-0.02	—

p0.203ANCOVA

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol

Time frame:baseline and 30 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Arm	-0.19	—
Placebo Arm	-0.00	—

p0.063ANCOVA

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol

Time frame:baseline and 30 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Arm	0.01	—
Placebo Arm	0.00	—

p0.745ANCOVA

Secondary/protocol endpoint

Change in Triglycerides

Time frame:baseline and 30 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Arm	-0.02	—
Placebo Arm	-0.03	—

p0.933ANCOVA

Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP)

Time frame:baseline and 30 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Arm	-2.74	—
Placebo Arm	1.71	—

p0.011ANCOVA

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP)

Time frame:baseline and 30 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Arm	-1.73	—
Placebo Arm	1.69	—

p<0.001ANCOVA

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Minor Hypoglycemia Rate Per Year

Time frame:baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject per year	95% CI
Exenatide Arm	1.61	—
Placebo Arm	1.55	—

p0.666Negative binomial regression model

Secondary/protocol endpoint

Percentage of Subjects Experiencing Minor Hypoglycemia

Time frame:baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage	95% CI
Exenatide Arm	24.8	—
Placebo Arm	28.7	—

p0.486Fisher Exact

Publications (5)

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

Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration.
Current medical research and opinion2014 Jul (month)PMID24621255doi:10.1185/03007995.2014.896329via clinicaltrials gov reference derived + pubmed nct search
Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long).
Diabetes care2012 Dec (month)PMID23043166doi:10.2337/dc12-1205via clinicaltrials gov reference derived + pubmed nct search
Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.
Postgraduate medicine2012 Jul (month)PMID22913891doi:10.3810/pgm.2012.07.2567via clinicaltrials gov reference derived + pubmed nct search
Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes.
Diabetes care2012 May (month)PMID22432107doi:10.2337/dc11-1434via clinicaltrials gov reference derived + pubmed nct search
Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial.
Annals of internal medicine2011 Jan 18PMID21138825doi:10.7326/0003-4819-154-2-201101180-00300via 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.