Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy

Conditions
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Diabetes

Intervention / Treatment
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* Drug: sitagliptin
* Drug: insulin dose increase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sitagliptin<br> | Drug: sitagliptin<br>* sitagliptin 100mg once daily, orally, for 24 weeks.<br>* Other names: Januvia;|
| Active Comparator: insulin dose increase<br> | Drug: insulin dose increase<br>* insulin dose increase<br>* Other names: Long acting insulin (Lantus);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of HbA1C |  | 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Sitagliptin, insulin, C-peptide