drugset / Trial / NCT01100125

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

NCT01100125

Phase 4 Completed 140 enrolled Seoul National University Bundang Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-04
Primary completion
2012-01
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitagliptin Small molecule 100 mg Oral
Comparator insulin glargine Protein / enzyme biologic