DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

34

Recruiting sites

—

Enrollment

222

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-10%

Primary endpoint

•HbA1c <7.0% achievement

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 IDNCT01003184
Org study IDH8O-EW-GWDL

Timeline

Milestones

Study first posted2009-10-28estimated
Results first posted2012-12-18estimated
Last update posted2015-04-07estimated
Study start2009-10 (month precision)
Primary completion2011-07actual (month precision)
Study completion2011-12actual (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 suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
•Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
•Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start

Exclusion criteria

•Have any contraindication for the OAD that they have been using
•Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
•Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
•Have been treated with drugs that promote weight loss, within 3 months of screening
•Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
•Have previously completed or withdrawn from this study or any other study investigating exenatide QW
•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 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

Endpoints (14)

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
7
Cardiometabolic biomarkers
5
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms95% CI
Exenatide Once Weekly-2.79—
Insulin Detemir0.88—
Least Squares Mean Difference-3.6795% CI-4.63 – -2.71p<.0001Mixed Models Analysis

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

Time frame:Baseline, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage95% CI
Exenatide Once Weekly44.134.7 – 53.9
Insulin Detemir11.46.0 – 19.1
Odds Ratio (OR)6.6095% CI3.17 – 13.73p<.0001Regression, Logistic
Secondary/protocol endpoint

Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage95% CI
Exenatide Once Weekly58.949.0 – 68.3
Insulin Detemir17.810.9 – 26.7
Odds Ratio (OR)7.0695% CI3.64 – 13.70p<.0001Regression, Logistic
Secondary/protocol endpoint

Change in HbA1c From Baseline to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percentage of total hemoglobin95% CI
Exenatide Once Weekly-1.32—
Insulin Detemir-0.91—
Least Squares Mean Difference-0.4195% CI-0.62 – -0.20p0.0001Mixed Models Analysis
Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint

Time frame:Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage95% CI
Exenatide Once Weekly66.757.1 – 75.3
Insulin Detemir54.344.3 – 64.0
Odds Ratio (OR)1.7995% CI1.00 – 3.18p0.0497Regression, Logistic

Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.

Secondary/protocol endpoint

Percentage of Patients Achieving ≤7.0% at Endpoint

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage95% CI
Exenatide Once Weekly51.441.7 – 61.0
Insulin Detemir34.325.3 – 44.2
Odds Ratio (OR)2.2195% CI1.24 – 3.96p0.0074Regression, Logistic

Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.

Secondary/protocol endpoint

Percentage of Patients Achieving ≤6.5% at Endpoint

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Percentage95% CI
Exenatide Once Weekly27.919.8 – 37.2
Insulin Detemir7.63.3 – 14.5
Odds Ratio (OR)4.8995% CI2.10 – 11.35p0.0002Regression, Logistic

Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.

Secondary/protocol endpoint

Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Exenatide Once Weekly-2.33—
Insulin Detemir-2.43—
Least Squares Mean Difference0.1095% CI-0.41 – 0.61p0.6993ANCOVA

ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Changes in Systolic Blood Pressure From Baseline to Week 26

Time frame:Baseline, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (least_squares_mean), mmHg95% CI
Exenatide Once Weekly-7.37—
Insulin Detemir-2.65—
Least Squares Mean Difference-4.7295% CI-8.37 – -1.07p0.0116Mixed Models Analysis
Secondary/protocol endpoint

Change in Diastolic Blood Pressure From Baseline to Week 26.

Time frame:Baseline, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (least_squares_mean), mmHg95% CI
Exenatide Once Weekly-0.79-1.79 – 0.56
Insulin Detemir-0.34-2.05 – 0.39
Least Squares Mean Difference-0.4595% CI-2.77 – 1.88p0.7034Mixed Models Analysis
Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Endpoint (Week 26).

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Exenatide Once Weekly-0.09-0.22 – 0.04
Insulin Detemir0.06-0.08 – 0.19
Least Squares Mean Difference-0.1595% CI-0.32 – 0.03p0.1061ANCOVA

ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.

Secondary/protocol endpoint

Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).

Time frame:Baseline, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Exenatide Once Weekly0.02-0.01 – 0.05
Insulin Detemir0.040.01 – 0.06
Least Squares Mean Difference-0.0195% CI-0.05 – 0.02p0.4638ANCOVA

ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.

Secondary/protocol endpoint

Change in Triglycerides From Baseline to Endpoint (Week 26).

Time frame:Baseline, Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Exenatide Once Weekly-0.01-0.17 – 0.15
Insulin Detemir-0.08-0.24 – 0.08
Least Squares Mean Difference0.0795% CI-0.14 – 0.28p0.4967ANCOVA

ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Hypoglycemia Rate Per Year

Time frame:Baseline, Week 26

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), events per subject-year95% CI
Exenatide Once Weekly0.060.02 – 0.20
Insulin Detemir0.100.03 – 0.30
Ratio0.5895% CI0.19 – 1.72p0.3247Poisson regression

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

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.