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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014