GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

494

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c 6.5-10%

Primary endpoints

•HbA1c, change•Documented hypoglycemia (Documented hypoglycemia, Severe 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 IDNCT00434954

Org study IDH8O-SB-GWBN

Timeline

Milestones

Study first posted2007-02-14estimated

Results first posted2010-08-23estimated

Last update posted2015-04-07estimated

Study start2007-02 (month precision)

Primary completion2009-06actual (month precision)

Study completion2009-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start

•Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start

•Have an HbA1c between 6.5% and 10.0%, inclusive

•Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive

Exclusion criteria

•Have type 1 diabetes or known latent autoimmune diabetes in adults

•Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start

•Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)

•Have used any prescription drug to promote weight loss within 3 months prior to study start

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

•Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs

Endpoints (12)

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

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:Baseline and 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Twice Daily	-4.10	—
Premixed Insulin Aspart Twice Daily	1.02	—

p<0.0001Mixed effects model repeated measures

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline and 26 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/m^2	95% CI
Exenatide Twice Daily	-1.39	—
Premixed Insulin Aspart Twice Daily	0.32	—

p<0.0001Mixed effects model repeated measures

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline and 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of glycosylated hemoglobin	95% CI
Exenatide Twice Daily	-1.00	—
Premixed Insulin Aspart Twice Daily	-1.14	—

Mean Difference (Net)0.1495% CI-0.003 – 0.291p0.055Mixed effect model repeat measures(MMRM)

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of < 6.5%

Time frame:26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide Twice Daily	27.6	—
Premixed Insulin Aspart Twice Daily	24.9	—

p0.554Chi square test (Pearson)

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of < 7.0%

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide Twice Daily	49.2	—
Premixed Insulin Aspart Twice Daily	56.6	—

p0.159Chi square test (Pearson)

Secondary/protocol endpoint

7 Point Self-monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline and 26 weeks

descriptive

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide Twice DailyPre-breakfast at baseline (week 0)	8.933	—
Pre-breakfast at endpoint (week 26)	7.774	—
2 hrs post-breakfast at baseline (week 0)	10.821	—
2 hrs post-breakfast at endpoint (week 26)	8.014	—
Pre-lunch at baseline (week 0)	8.443	—
Pre-lunch at endpoint (week 26)	7.506	—
2 hrs post-lunch at baseline (week 0)	9.698	—
2 hrs post-lunch at endpoint (week 26)	8.513	—
Pre-dinner at baseline (week 0)	8.684	—
Pre-dinner at endpoint (week 26)	7.616	—
2 hrs post-dinner at baseline (week 0)	10.241	—
2 hrs post-dinner at endpoint (week 26)	7.727	—
3:00 am at baseline (week 0)	8.323	—
3:00 am at endpoint (week 26)	7.518	—
Premixed Insulin Aspart Twice DailyPre-breakfast at baseline (week 0)	9.005	—
Pre-breakfast at endpoint (week 26)	7.293	—
2 hrs post-breakfast at baseline (week 0)	10.902	—
2 hrs post-breakfast at endpoint (week 26)	8.304	—
Pre-lunch at baseline (week 0)	8.357	—
Pre-lunch at endpoint (week 26)	6.656	—
2 hrs post-lunch at baseline (week 0)	9.899	—
2 hrs post-lunch at endpoint (week 26)	8.216	—
Pre-dinner at baseline (week 0)	8.759	—
Pre-dinner at endpoint (week 26)	7.194	—
2 hrs post-dinner at baseline (week 0)	10.259	—
2 hrs post-dinner at endpoint (week 26)	8.143	—
3:00 am at baseline (week 0)	8.475	—
3:00 am at endpoint (week 26)	6.999	—

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Blood Lipid Levels

Time frame:Baseline and 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Exenatide Twice DailyTotal cholesterol at baseline (week 0)	5.147	—
Total cholesterol at endpoint (week 26)	4.971	—
HDL cholesterol at baseline (week 0)	1.234	—
HDL cholesterol at endpoint (week 26)	1.244	—
LDL cholesterol (calculated) at baseline (week 0)	2.845	—
LDL cholesterol (calculated) at endpoint (week 26)	2.738	—
Triglycerides at baseline (week 0)	2.391	—
Triglycerides at endpoint (week 26)	2.234	—
Premixed Insulin Aspart Twice DailyTotal cholesterol at baseline (week 0)	5.084	—
Total cholesterol at endpoint (week 26)	5.050	—
HDL cholesterol at baseline (week 0)	1.255	—
HDL cholesterol at endpoint (week 26)	1.319	—
LDL cholesterol (calculated) at baseline (week 0)	2.768	—
LDL cholesterol (calculated) at endpoint (week 26)	2.852	—
Triglycerides at baseline (week 0)	2.410	—
Triglycerides at endpoint (week 26)	2.006	—

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Time frame:Baseline and 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), scores on DTSQ scale	95% CI
Exenatide Twice DailyDTSQ score at baseline (week 0)	29.5	—
DTSQ score at endpoint (week 26)	30.6	—
Premixed Insulin Aspart Twice DailyDTSQ score at baseline (week 0)	29.7	—
DTSQ score at endpoint (week 26)	29.3	—

Secondary/protocol endpoint

Patient Reported Outcomes: Quality of Life (SF-12)

Time frame:Baseline and 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), scores on SF-12 scale	95% CI
Exenatide Twice DailyPhysical Component at baseline (week 0)	35.5	—
Physical Component at endpoint (week 26)	39.1	—
Mental Component at baseline (week 0)	31.3	—
Mental Component at endpoint (week 26)	31.1	—
Premixed Insulin Aspart Twice DailyPhysical Component at baseline (week 0)	36.3	—
Physical Component at endpoint (week 26)	37.7	—
Mental Component at baseline (week 0)	28.3	—
Mental Component at endpoint (week 26)	29.6	—

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)

Time frame:26 weeks

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide Twice Daily	8.0	—
Premixed Insulin Aspart Twice Daily	20.5	—

p<0.05Kaplan-Meier analysis

Secondary/protocol endpoint

Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)

Time frame:26 weeks

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide Twice Daily	1.8	—
Premixed Insulin Aspart Twice Daily	6.3	—

Secondary/protocol endpoint

Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)

Time frame:26 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide Twice Daily	3.9	—
Premixed Insulin Aspart Twice Daily	7.0	—

Publications (2)

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

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
Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia.
Diabetes care2011 Mar (month)PMID21285388doi:10.2337/dc10-1900via 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.