Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus

NCT00425490 | Completed Phase 3

• 1 other identifier: SHEBA-06-4373-OC-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (4)

• 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.

Interventions

sitagliptin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Patient is currently not on an AHA and has a Visit 1 HbA1c ≥6.5% and ≤10%. OR
• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba_Medical_Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Ohad Cohen, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 23, 2009

Record last verified: 2009-09

Locations

IL (1)