NCT01422590

Brief Summary

  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started May 2010

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

11 months

First QC Date

August 10, 2011

Last Update Submit

September 6, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

sitagliptinmitiglinidetype 2 diabetes mellitusPharmacodynamicsSafety

Outcome Measures

Primary Outcomes (7)

  • 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

    day 1 and day 2 of each period

  • AUC of insulin

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

    day 1 and day 2 of each period

  • AUC of intact GLP-1

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

    day 1 and day 2 of each period

  • AUC of C-peptide

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

    day 1 and day 2 of each period

  • AUC of glucagon

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

    day 1 and day 2 of each period

  • MAGE

    Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups

    day 1 and day 2 of each period

  • AUC of DPP-4 activity

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

    day 1 and day 2 of each period

Study Arms (3)

Sitagliptin

ACTIVE COMPARATOR
Drug: Sitagliptin

Mitiglinide

ACTIVE COMPARATOR
Drug: Mitiglinide

Sitagliptin + Mitiglinide

EXPERIMENTAL
Drug: Sitagliptin, Mitiglinide

Interventions

SitagliptinDRUG

Single oral administration of sitagliptin 100 mg

Sitagliptin
MitiglinideDRUG

Single oral administration of mitiglinide 10 mg

Mitiglinide
Sitagliptin, MitiglinideDRUG

Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg

Sitagliptin + Mitiglinide

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients with type 2 diabetes mellitus
  • % ≤ 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
  • kg/m2 ≤ body mass index \< 30 kg/m2

You may not qualify if:

  • Fasting glucose ≥ 200 mg/dL
  • Required insulin therapy
  • Patients with neuropathy, retinopathy or renopathy
  • Contraindicated for mitiglinide or sitagliptin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24249434DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphatemitiglinide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Wooseong Hur, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 24, 2011

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

KR(1)