Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00425490

Purpose

The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mg/day on the insulin secretion capacity of beta cells.

Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization and after a 12-wk double-blind study period. The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: sitagliptin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase III Study on the Effect of Sitagliptin on Maximal Beta Cell Stimulation

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

FPG,
HbA1c,
β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin,
C-peptide total and incremental area under the curve.

Estimated Enrollment:	30
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2007

Detailed Description:

Study design and duration: This will be an Israeli three center study. Study drug: Sitagliptin 100 mg. The study will be a double blind, randomized two arms parallel group study. The duration of the study will be up to 18 weeks (with 8 visits) for each patient. This will include: a screening period of up to 4 weeks (Visit 1 to visit 2), a 2 week single blind, placebo run-in period (visit 2 to visit 4), and a 12 week placebo controlled, double blind treatment period (visit 4 to visit 8).

Patients with T2DM who have not been treated with an AHA, or who are on AHA monotherapy or low dose oral combination therapy (low dose defined as ≤50% of the maximum labeled dose of each agent), may participate if they meet all enrollment criteria. Patients eligible to be randomized will have a HbA1c ³6.5% and £10% .

Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization (Visit 3 and 4). These experiments will be will be completed after a 12-hour overnight fast. The 2 experiments will be repeated at the conclusion of the 12-wk double-blind study period (Visits 7 and 8).

Efficacy measurements: (1) Glycemic control : FPG, HbA1c, β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin, C-peptide total and incremental area under the curve.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patient has T2DM diagnosed within the past 5 years
Patient is >18 and <65 years of age
Patient is not pregnant, breast feeding and unlikely to conceive
Patient understands the study procedures, and agrees to participate in the study by giving written informed consent
Patient meets one of the following criteria:
1. Patient is currently not on an AHA and has a Visit 1 HbA1c ≥6.5% and ≤10%. OR
2. Patient is currently on AHA monotherapy or low dose (i.e. ≤50% maximum labeled dose of each agent) oral combination therapy and has a Screening/Visit 1 HbA1c ≥6.5% and ≤9.5%.
At visit 2, patient has a HbA1c of ≥6.5% and ≤10%

Exclusion Criteria:

Patient has type 1 diabetes mellitus
Patient required insulin therapy within 12 weeks of Visit 1. Note: patients who received a brief period of insulin treatment (e.g., several days during a hospitalization) and who are no longer requiring insulin treatment may participate
Patient is currently or within 12 weeks of Visit 1 taking a TZD agent as monotherapy or in combination
Patient is currently or within 12 weeks of Visit 1 taking Byetta.
Patient is on corticosteroids
Patient has a history of malignancy ≤5 years prior to signing informed consent, or >5 years without documentation of remission/cure Exception: Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded -Patient is on chemotherapy
Patient received another investigational drug in the last 12 weeks.
Patients with concomitant liver disease and or AST > 3 fold upper limit of normal
Patients with kidney disease or CR>1.4 mg/dl
Patients with anemia ( Hb <11 gr in male 10 gr in female)
Patient with active vascular disease (coronary, peripheral or cerebrovascular)
Patient has poorly controlled hypertension defined as systolic blood pressure >160 mm Hg or diastolic >95 mm Hg
Proliferative retinopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425490

Contacts

Contact: Ohad Cohen, MD

972-3-5302372

Ohad.cohen@sheba.health.gov.il

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Ohad Cohen, MD	Sheba Medical Center
Principal Investigator:	Ohad Cohen, MD	Sheba Medical Center

More Information

Study ID Numbers:	SHEBA-06-4373-OC-CTIL
Study First Received:	January 22, 2007
Last Updated:	January 22, 2007
ClinicalTrials.gov Identifier:	NCT00425490
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009