Clinical trial NCT01100125: Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment
Official title: Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetes
Sitagliptin
insulin
C-peptide
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-04-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The change of HbA1C
timeFrame: 24weeks
Secondary outcomes:
measure: the number of patients in HbA1C <7% without hypoglycemia
timeFrame: 24 weeks
measure: hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL)
timeFrame: 24 weeks
measure: the change of C-peptide
timeFrame: 24 weeks
measure: the change of body weight and waist circumference
timeFrame: 24 weeks
measure: the change of insulin dose
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
citation: Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, Jang HC, Shin H, Walford GA, Lim S. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012 Sep;14(9):795-802. doi: 10.1111/j.1463-1326.2012.01600.x. Epub 2012 Apr 18.