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Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422590
First Posted: August 24, 2011
Last Update Posted: September 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Samsung Medical Center
  Purpose
  1. Explore pharmacodynamics

    • glucose
    • insulin
    • C-peptide
    • glucagon
    • intact GLP-1
    • DPP-4 activity
    • CGMS (continuous glucose monitoring system)
  2. Assess Safety

    • adverse events
    • clinical laboratory test
    • physical examination

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Mitiglinide Drug: Sitagliptin, Mitiglinide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • AUC (area under the curve) of plasma glucose [ Time Frame: day 1 and day 2 of each period ]
    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  • AUC of insulin [ Time Frame: day 1 and day 2 of each period ]
    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  • AUC of intact GLP-1 [ Time Frame: day 1 and day 2 of each period ]
    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  • AUC of C-peptide [ Time Frame: day 1 and day 2 of each period ]
    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  • AUC of glucagon [ Time Frame: day 1 and day 2 of each period ]
    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  • MAGE [ Time Frame: day 1 and day 2 of each period ]
    Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  • AUC of DPP-4 activity [ Time Frame: day 1 and day 2 of each period ]
    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups


Enrollment: 26
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sitagliptin Drug: Sitagliptin
Single oral administration of sitagliptin 100 mg
Active Comparator: Mitiglinide Drug: Mitiglinide
Single oral administration of mitiglinide 10 mg
Experimental: Sitagliptin + Mitiglinide Drug: Sitagliptin, Mitiglinide
Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg

Detailed Description:

Pharmacodynamic assessment

  • CGMS data is obtained from day 1 to day 3 (48 hours)
  • PD is measured before (day 1) and after drug administration (day 2)

    1. AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
    2. MAGE (mean amplitude of glycemic excursion) from CGMS data
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients with type 2 diabetes mellitus
  • 6.5% ≤ HbA1c < 9.0%
  • Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
  • Stopped treatment of other anti-diabetic agents for more than 12 weeks
  • 16 kg/m2 ≤ body mass index < 30 kg/m2

Exclusion Criteria:

  • Fasting glucose ≥ 200 mg/dL
  • Required insulin therapy
  • Patients with neuropathy, retinopathy or renopathy
  • Contraindicated for mitiglinide or sitagliptin
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422590


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
JW Pharmaceutical
Investigators
Principal Investigator: Wooseong Hur, MD, PhD Samsung Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01422590     History of Changes
Other Study ID Numbers: 2010-04-071
First Submitted: August 10, 2011
First Posted: August 24, 2011
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Samsung Medical Center:
sitagliptin
mitiglinide
type 2 diabetes mellitus
Pharmacodynamics
Safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mitiglinide
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action