Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

This study has been completed.
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01422590
First received: August 10, 2011
Last updated: September 6, 2011
Last verified: September 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Samsung Medical Center

Additional 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
Study First Received: August 10, 2011
Last Updated: September 6, 2011
Health Authority: Korea: Food and Drug Administration

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014