DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT00551590

CompletedPhase 1

Effect of Sitagliptin on Incretin Effect in Patients With Type 2 Diabetes Mellitus

A Randomized, Placebo-Controlled, 4-period, Crossover Study to Assess the Impact of MK-0431 (Sitagliptin) on Incretin Effect and the Role of Specific Incretin Hormones in Patients With Type 2 Diabetes Mellitus

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

24

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•HbA1c ≤9%

Primary endpoint

•To asses the effect of sitagliptin

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 IDNCT00551590
Org study IDSITEX-02
Secondary IDEudraCT 2007-001050-83

Timeline

Milestones

Study first posted2007-10-31estimated
Last update posted2011-10-04estimated
Study start2007-12 (month precision)
Primary completion2008-12actual (month precision)
Study completion2011-09actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Women with T2DM without childbearing potential
•Male patients with T2DM using a double-barrier method of contraception
•must be able to complete a 1 week wash-out of current anti-diabetic medications (patients on PPARγ must be off for at least 4 weeks)
•no medications which may alter gastric motility (i.e. acetaminophen, erythromycin) except for cardiac medication at a stable dose.
•Age 30-70 years
•HbA1c ≤9% at screening
•BMI<40 kg/m2
•Must have a fasting blood glucose of ≤11.1 mmol/L (200 mg/dL) at screening
•Able to provide written informed consent prior to study participation
•Able to communicate well with the investigator and comply with the requirements of the study
•Able to maintain dietetic restrictions and to perform measurements of blood glucose on a daily basis (fasting and two-hours postprandial). Patients must be informed the investigator if fasting glucose is above 200mg/dl or two hours postprandially blood glucose concentration above 240mg/dl is being measured.

Exclusion criteria

•T1DM, diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg. Cushing, acromegaly)
•Females with childbearing potential, breastfeeding and pregnant women
•Need for insulin within the previous 3 months
•Use of Thiazolidinediones in the previous 4 weeks
•Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
•Fasting triglycerides >5.1 mmol/L (>450 mg/dL) within the past 4 weeks.
•Treatment with systemic steroids and thyroid hormone (unstable dosage).
•Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
•Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
•Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
•Significant illness within the two weeks prior to dosing.
•Past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
•History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
•Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following:
–history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
–history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
–history or clinical evidence of pancreatic injury or pancreatitis;
–history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria);
–evidence of urinary obstruction or difficulty in voiding at screening;
•Polymorphonuclears <1500/µL at inclusion or platelet count < 100,000/μL at screening and base-line.
•History of immunocompromise.
•Evidence of liver disease as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. SGOT, SGPT, GGT and alkaline phosphatase must not exceed twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).
•History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations.

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/low confidence

To asses the effect of sitagliptin compared to placebo and to coadministration of sitagliptin and the GLP-1 receptor antagonist exendin(9-39)NH2 on the incretin effect after an oral glucose challenge.

Time frame:during 240 minutes after ingestion of an OGTT

descriptive

Secondary/protocol endpoint/low confidence

Plasma glucagon, plasma GIP, plasma GLP-1, Insulin, C-peptide, plasma glucose profiles. 13CO2 exhalation kinetics assessing gastric emptying

Time frame:during 240 minutes after ingestion of an OGTT

descriptive

Publications (4)

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.