Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Bundang Hospital
Treatments:
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Sitagliptin Phosphate
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