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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00425490
First received: January 22, 2007
Last updated: September 22, 2009
Last verified: September 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase III Study on the Effect of Sitagliptin on Maximal Beta Cell Stimulation

Resource links provided by NLM:


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
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

Locations
Israel
Sheba_Medical_Center
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ohad Cohen, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Ohad Cohen, Sheba medical center
ClinicalTrials.gov Identifier: NCT00425490     History of Changes
Other Study ID Numbers: SHEBA-06-4373-OC-CTIL
Study First Received: January 22, 2007
Last Updated: September 22, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014