GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes

Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily

Lead sponsor

Profil Institut für Stoffwechselforschung GmbH

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•Postprandial glucose

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 IDNCT00971659

Org study ID49/0316-Adjunct

Timeline

Milestones

Study first posted2009-09-04estimated

Last update posted2009-09-04estimated

Study start2008-01 (month precision)

Primary completion2008-09actual (month precision)

Study completion2008-11actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•male or female subjects aged between 35 and 70 years, inclusive

•type 2 diabetes with duration >6 months and <10 years

•for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas

•HbA1c >=7.0% and <=10.0%

•if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start

•written informed consent

Exclusion criteria

•history or presence of cancer or any clinically relevant diseases

•chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months

•recurrent hypoglycemia

•abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females

•clinically relevant ECG findings at screening

•treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months

•treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months

•any systemic or topical treatment with drugs known to influence glucose metabolism

Endpoints (2)

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.

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast

Time frame:after 4 weeks of treatment

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint/low confidence

mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes

Time frame:after 4 weeks of treatment

descriptive, improvement

componentsPostprandial glucose, Fasting glucose, change, HbA1c <7.0% achievement, Triglycerides, change, LDL-C, change, HDL-C, change, Total cholesterol, change, HOMA-IR (insulin sensitivity), Documented hypoglycemia

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

Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study.
Diabetes care2010 Jul (month)PMID20357372doi:10.2337/dc09-2191via 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 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.