Clinical trial NCT00969566: Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination
Official title: Predictive Parameters for Therapeutic Efficacy of Initial Combination Therapy With Sitagliptin and Metformin in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetes
Sitagliptin
C-peptide
Glucagon
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change of HbA1c
timeFrame: 52 weeks
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: 52 weeks
measure: Postprandial Plasma Glucose (PPG)
timeFrame: 52 weeks
measure: C-peptide
timeFrame: 52 weeks
measure: Glucagon
timeFrame: 52 weeks
measure: Homeostatic model assessment of insulin resistance (HOMA-IR)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD, MPH, PHD
role: PRINCIPAL_INVESTIGATOR
References: