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Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment

NCT ID: NCT01100125

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Keywords

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Diabetes Sitagliptin insulin C-peptide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sitagliptin

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

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

insulin dose increase

Group Type ACTIVE_COMPARATOR

insulin dose increase

Intervention Type DRUG

insulin dose increase

Interventions

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sitagliptin

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

Intervention Type DRUG

insulin dose increase

insulin dose increase

Intervention Type DRUG

Other Intervention Names

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Januvia Long acting insulin (Lantus)

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* HbA1c ≥ 7%
* Age ≥ 18
* Insulin treatment with or without oral antidiabetic medication

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Assisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 22443183 (View on PubMed)

Other Identifiers

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SNUBH_ENDO2

Identifier Type: -

Identifier Source: org_study_id