Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment
Information source: Seoul National University Bundang Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes
Intervention: sitagliptin (Drug); insulin dose increase (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Seoul National University Bundang Hospital
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.
Clinical Details
Official title: Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The change of HbA1C
Secondary outcome: the number of patients in HbA1C <7% without hypoglycemiahypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL) the change of C-peptide the change of body weight and waist circumference the change of insulin dose
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Gyeonggi 463-707, Korea, Republic of
Additional Information
Starting date: April 2010
Last updated: October 24, 2013
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