DelfaGLP-1 Atlas

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CompletedPhase 3

Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

Effects of NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets With Metformin and a Sulfonylurea

Lead sponsor

Novo Nordisk A/S

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

373

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥8%

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 IDNCT00313001
Org study IDBIASP-1714

Timeline

Milestones

Study first posted2006-04-11estimated
Last update posted2017-01-06estimated
Study start2006-04 (month precision)
Primary completion2007-07actual (month precision)
Study completion2007-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes
•HbA1C: At least 8%
•Patients that were never treated with insulin before
•Current therapy with metformin and a sulfonylurea.

Exclusion criteria

•History of recurrent, severe hypoglycemia
•Hepatic insufficiency: ALT, AST or alkaline phosphatase > 2.5 times upper limits of laboratory's normal
•Renal insufficiency: serum creatinine > 1.3 mg/dL (males) or > 1.2 mg/dL (females)
•Severe gastrointestinal disease, including gastroparesis

Endpoints (3)

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
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Superiority as assessed by HbA1c reduction

Time frame:at 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Patient satisfaction

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety variables

descriptive

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 tableno registry results posted yet

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.