NCT01100125

Brief Summary

It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication 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 glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment. The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Apr 2010

Typical duration for phase_4 diabetes

Geographic Reach
1 country

2 active sites

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

April 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.8 years

First QC Date

April 5, 2010

Last Update Submit

October 24, 2013

Conditions

Diabetes

Keywords

DiabetesSitagliptininsulinC-peptide

Outcome Measures

Primary Outcomes (1)

  • The change of HbA1C

    24weeks

Secondary Outcomes (5)

  • the number of patients in HbA1C <7% without hypoglycemia

    24 weeks

  • hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL)

    24 weeks

  • the change of C-peptide

    24 weeks

  • the change of body weight and waist circumference

    24 weeks

  • the change of insulin dose

    24 weeks

Study Arms (2)

sitagliptin

EXPERIMENTAL
Drug: sitagliptin

insulin dose increase

ACTIVE COMPARATOR
Drug: insulin dose increase

Interventions

sitagliptinDRUG

sitagliptin 100mg once daily, orally, for 24 weeks.

Also known as: Januvia
sitagliptin
insulin dose increaseDRUG

insulin dose increase

Also known as: Long acting insulin (Lantus)
insulin dose increase

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
  • Insulin treatment with or without oral antidiabetic medication

You may not qualify if:

  • Contraindication to sitagliptin
  • Pregnant or breast feeding women
  • 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
  • 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 (2)

Seoul National University Bundang Hospital

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

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Related Publications (1)

  • Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, Jang HC, Shin H, Walford GA, Lim S. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012 Sep;14(9):795-802. doi: 10.1111/j.1463-1326.2012.01600.x. Epub 2012 Apr 18.

    PMID: 22443183DERIVED

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Sitagliptin PhosphateInsulin, Long-ActingInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 8, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2012

Study Completion

November 1, 2012

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

KR(2)