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

Information source: Seoul National University Bundang Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

Intervention: sitagliptin (Drug); insulin dose increase (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Bundang Hospital

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.

Clinical Details

Official title: Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The change of HbA1C

Secondary outcome:

the number of patients in HbA1C <7% without hypoglycemia

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

the change of C-peptide

the change of body weight and waist circumference

the change of insulin dose

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Gyeonggi 463-707, Korea, Republic of

Additional Information

Starting date: April 2010
Last updated: October 24, 2013

Page last updated: August 23, 2015

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