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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100125
• Other study ID #: SNUBH_ENDO2
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2010
• Last updated: October 24, 2013
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• sitagliptin
sitagliptin 100mg once daily, orally, for 24 weeks.
• insulin dose increase
insulin dose increase

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of HbA1C		24weeks	No
Secondary	the number of patients in HbA1C <7% without hypoglycemia		24 weeks	No
Secondary	hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL)		24 weeks	Yes
Secondary	the change of C-peptide		24 weeks	No
Secondary	the change of body weight and waist circumference		24 weeks	No
Secondary	the change of insulin dose		24 weeks	No