Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination

Diabetes Clinical Trial

— COSMETIC  

Official title:

Predictive Parameters for Therapeutic Efficacy of Initial Combination Therapy With Sitagliptin and Metformin in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969566
• Other study ID #: SNUBH_ENDO1
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2009
• Last updated: January 5, 2012
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• sitagliptin, metformin
sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.

Locations

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

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		52 weeks	Yes
Secondary	Fasting Plasma Glucose (FPG)		52 weeks	Yes
Secondary	Postprandial Plasma Glucose (PPG)		52 weeks	Yes
Secondary	C-peptide		52 weeks	Yes
Secondary	Glucagon		52 weeks	Yes
Secondary	Homeostatic model assessment of insulin resistance (HOMA-IR)		52 weeks	Yes