Diabetes
Conditions
Keywords
Diabetes, Sitagliptin, insulin, C-peptide
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.
Interventions
DRUGsitagliptin
sitagliptin 100mg once daily, orally, for 24 weeks.
DRUGinsulin dose increase
insulin dose increase
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1C | 24weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed