GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

1,036

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7-10%

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 IDNCT00960661

Org study IDH8O-EW-GWDM

Timeline

Milestones

Study first posted2009-08-18estimated

Results first posted2013-12-17estimated

Last update posted2015-04-07estimated

Study start2009-09 (month precision)

Primary completion2012-08actual (month precision)

Study completion2012-08actual (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 been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.

•Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:

–Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or

–Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.

•Have an HbA1C > 7.0% and ≤ 10.0%.

•Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.

Exclusion criteria

•Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.

•Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).

•Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.

•Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.

•Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

•Have previously completed or been withdrawn from this study after enrollment.

Endpoints (13)

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 30.

Time frame:baseline, week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide (BET)	-2.45	—
Insulin Lispro (BBT)	2.11	—

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30

Time frame:Baseline, 30 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent of hemoglobin	95% CI
Exenatide (BET)	-1.13	—
Insulin Lispro (BBT)	-1.10	—

Mean Difference (Final Values)-0.0495% CI-0.18 – 0.11p0.6273Mixed model repeated measures

The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1C < 7.0%

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide (BET)	46.7	—
Insulin Lispro (BBT)	42.6	—

Secondary/protocol endpoint

Percent of Participants Achieving HbA1c ≤ 6.5%.

Time frame:Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Exenatide (BET)	26.2	—
Insulin Lispro (BBT)	25.5	—

Secondary/protocol endpoint

Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.

Time frame:Baseline, Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide (BET)	-0.46	—
Insulin Lispro (BBT)	0.18	—

Secondary/protocol endpoint/low confidence

Daily Insulin Glargine Dose at Baseline and at Week 30

Time frame:Baseline, week 30

descriptive

Posted result

Group	Value (mean), IU/day	95% CI
Exenatide (BET)Baseline	61.5	—
Week 30	56.9	—
Insulin Lispro (BBT)Baseline	61.1	—
Week 30	51.5	—

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 30

Time frame:Baseline, week 30

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide (BET)	-0.14	—
Insulin Lispro (BBT)	-0.03	—

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) From Baseline to Week 30

Time frame:Baseline, week 30

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide (BET)	-0.04	—
Insulin Lispro (BBT)	0.03	—

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) From Baseline to Week 30

Time frame:Baseline, Week 30

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide (BET)	-0.12	—
Insulin Lispro (BBT)	-0.03	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP) From Baseline to Week 30

Time frame:Baseline, Week 30

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide (BET)	-4.13	—
Insulin Lispro (BBT)	0.37	—

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30

Time frame:baseline, Week 30

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide (BET)	-0.64	—
Insulin Lispro (BBT)	-0.14	—

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Major Hypoglycemia Rate Per Year

Time frame:30 weeks

Severe hypoglycemia

event count, event

Posted result

Group	Value (mean), rate per year	95% CI
Exenatide (BET)	0.0	0 – 0
Insulin Lispro (BBT)	0.1	0 – 0

Secondary/protocol endpoint

Minor Hypoglycemia Rate Per Year

Time frame:30 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), rate per year	95% CI
Exenatide (BET)	2.1	1.45 – 2.07
Insulin Lispro (BBT)	5.0	3.26 – 4.54

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

Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Diabetes care2014 Oct (month)PMID25011946doi:10.2337/dc14-0876via CT.gov reference + 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.