NCT00969566

Brief Summary

It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. Their mechanism of action is derived from increased incretin (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. Recent studies reported that combination therapy with DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the difference of glucose lowering effect of combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of pancreas. The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. The researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Jan 2009

Typical duration for phase_4 diabetes

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

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

August 31, 2009

Last Update Submit

January 5, 2012

Conditions

Diabetes

Keywords

DiabetesSitagliptinC-peptideGlucagon

Outcome Measures

Primary Outcomes (1)

  • The change of HbA1c

    52 weeks

Secondary Outcomes (5)

  • Fasting Plasma Glucose (FPG)

    52 weeks

  • Postprandial Plasma Glucose (PPG)

    52 weeks

  • C-peptide

    52 weeks

  • Glucagon

    52 weeks

  • Homeostatic model assessment of insulin resistance (HOMA-IR)

    52 weeks

Study Arms (1)

Metformin+Sitagliptin

EXPERIMENTAL

Initial combination of metformin and sitagliptin

Drug: sitagliptin, metformin

Interventions

sitagliptin, metforminDRUG

sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.

Also known as: Januvia
Metformin+Sitagliptin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • HbA1c ≥ 7%
  • Age ≥ 18

You may not qualify if:

  • Contraindication to sitagliptin or metformin
  • Pregnant or breast feeding women
  • Reproductive-age women who refuse contraception
  • Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
  • Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
  • Renal failure (Cr \> 2.0)
  • Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)
  • Not appropriate for oral antidiabetic agent
  • Medication which affect glycemic control
  • Disease which affect efficacy and safety of drugs
  • Other clinical trial within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin PhosphateMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Soo Lim, MD, MPH, PHD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2011

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

KR(1)