Back to resultsPharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sitagliptin
Mitiglinide
Sitagliptin, Mitiglinide
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring sitagliptin, mitiglinide, type 2 diabetes mellitus, Pharmacodynamics, Safety
Eligibility 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Sitagliptin
Mitiglinide
Sitagliptin + Mitiglinide
Arm Description
Outcomes
Primary Outcome Measures
AUC (area under the curve) of plasma glucose
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of insulin
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of intact GLP-1
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of C-peptide
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of glucagon
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
MAGE
Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of DPP-4 activity
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Secondary Outcome Measures
Full Information
NCT ID
NCT01422590
First Posted
August 10, 2011
Last Updated
September 6, 2011
Sponsor
Samsung Medical Center
Collaborators
JW Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01422590
Brief Title
Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
Official Title
Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Explore pharmacodynamics
glucose
insulin
C-peptide
glucagon
intact GLP-1
DPP-4 activity
CGMS (continuous glucose monitoring system)
Assess Safety
adverse events
clinical laboratory test
physical examination
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)
AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
MAGE (mean amplitude of glycemic excursion) from CGMS data
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
sitagliptin, mitiglinide, type 2 diabetes mellitus, Pharmacodynamics, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Title
Mitiglinide
Arm Type
Active Comparator
Arm Title
Sitagliptin + Mitiglinide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
Single oral administration of sitagliptin 100 mg
Intervention Type
Drug
Intervention Name(s)
Mitiglinide
Intervention Description
Single oral administration of mitiglinide 10 mg
Intervention Type
Drug
Intervention Name(s)
Sitagliptin, Mitiglinide
Intervention Description
Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg
Primary Outcome Measure Information:
Title
AUC (area under the curve) of plasma glucose
Description
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
Title
AUC of insulin
Description
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
Title
AUC of intact GLP-1
Description
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
Title
AUC of C-peptide
Description
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
Title
AUC of glucagon
Description
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
Title
MAGE
Description
Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
Title
AUC of DPP-4 activity
Description
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
Time Frame
day 1 and day 2 of each period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wooseong Hur, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24249434
Citation
Jung JA, Kaku K, Kim JH, Kim JR, Ko JW, Lee SY, Huh W. Additive postprandial glucose-lowering effects of mitiglinide and sitagliptin in patients with type 2 diabetes mellitus. Adv Ther. 2013 Nov;30(11):1018-29. doi: 10.1007/s12325-013-0072-x. Epub 2013 Nov 19. Erratum In: Adv Ther. 2014 Jan;31(1):149.
Results Reference
derived
Learn more about this trial
Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin
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