Diabetes
Conditions
Keywords
Diabetes, Sitagliptin, C-peptide, Glucagon
Brief summary
It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. Their mechanism of action is derived from increased incretin (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. Recent studies reported that combination therapy with DPP-IV inhibitors and metformin 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 difference of glucose lowering effect of combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of pancreas. The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. The researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.
Interventions
DRUGsitagliptin, metformin
sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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
Exclusion criteria
* Contraindication to sitagliptin or metformin * Pregnant or breast feeding women * Reproductive-age women who refuse contraception * 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 (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) * 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 | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose (FPG) | 52 weeks |
| Postprandial Plasma Glucose (PPG) | 52 weeks |
| C-peptide | 52 weeks |
| Glucagon | 52 weeks |
| Homeostatic model assessment of insulin resistance (HOMA-IR) | 52 weeks |
Countries
South Korea
Outcome results
None listed