GLP-1 Peptide Atlas, by Delfa

CompletedPhase NAResults posted

Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis

Lead sponsor

HealthPartners Institute

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

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 IDNCT01089569

Org study ID03951-10-C

Timeline

Milestones

Study first posted2010-03-18estimated

Last update posted2017-05-23actual

Results first posted2017-05-23actual

Study start2010-04 (month precision)

Primary completion2013-05actual (month precision)

Study completion2013-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects ≥18 and ≤75 years of age

•Clinical diagnosis of type 2 diabetes

•Diabetes duration ≥ 1 year

•HbA1c ≥7.0%

•Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion criteria

•Previously treated with insulin or incretin-based therapy

•Treated with a thiazolidinedione within past 6 weeks

•Taken oral or injected prednisone or cortisone medications in the previous 30 days

•Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)

•Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)

•eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)

•ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)

•Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study

•Currently pregnant or planning pregnancy during the study period

•Unable to follow the study protocol

•Unable to speak, read and write in English

•Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy

•At the investigator's discretion for other medical or psychological reasons

Endpoints (7)

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

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Weight Changes

Time frame:baseline - final visit (32 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), lbs (pounds)	95% CI
Exenatide	-13.5	—
Insulin Glargine	-0.5	—
Exenatide + Insulin Glargine	-10.3	—

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

HbA1c Change

Time frame:baseline to final visit (32 weeks)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), %HbA1c	95% CI
ExenatideBaseline	6.4	—
Final - Week 32	7.8	—
Insulin GlargineBaseline	6.4	—
Final - Week 32	7.6	—
Exenatide + Insulin GlargineBaseline	6.2	—
Final - Week 32	7.6	—

Secondary/protocol endpoint

Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)

Time frame:baseline to final visit (32 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL/hr	95% CI
Exenatide	-2	—
Insulin Glargine	-2.9	—
Exenatide + Insulin Glargine	-2	—

Secondary/protocol endpoint

Change From Baseline in CGM Glucose Variability

Time frame:baseline to final visit (32 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Exenatide	-9	—
Insulin Glargine	-7.7	—
Exenatide + Insulin Glargine	-12.1	—

Secondary/protocol endpoint

Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)

Time frame:baseline - final visit (32 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL*24hr	95% CI
Exenatide	-1207.1	—
Insulin Glargine	-1476.2	—
Exenatide + Insulin Glargine	-1315	—

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Incidence of Hypoglycemia (Frequency)

Time frame:baseline to final visit (32 weeks)

Documented hypoglycemia

change from baseline, event

Posted result

Group	Value (mean), episodes/day	95% CI
Exenatide	.7	—
Insulin Glargine	.8	—
Exenatide + Insulin Glargine	.6	—

Secondary/protocol endpoint

Change From Baseline in Incidence of Hypoglycemia (Degree)

Time frame:baseline to final visit (32 weeks)

Documented hypoglycemia

change from baseline, event

Posted result

Group	Value (mean), percentage of measures under 70 mg/dL	95% CI
Exenatide	1.7	—
Insulin Glargine	1.7	—
Exenatide + Insulin Glargine	1.3	—

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

Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2009 May-Jun (year)PMID19454385doi:10.4158/EP09046.ORRvia CT.gov background
Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis.
Diabetes technology & therapeutics2008 Jun (month)PMID18473688doi:10.1089/dia.2007.0293via CT.gov background

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.