Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Diabetes |
Intervention | Drug: sitagliptin, metformin |
Phase | Phase 4 |
Sponsor | Seoul National University Bundang Hospital |
Responsible Party | Seoul National University Bundang Hospital |
ClinicalTrials.gov Identifier | NCT00969566 |
First Received | August 31, 2009 |
Last Updated | January 5, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | August 31, 2009 |
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Last Updated Date | January 5, 2012 |
Start Date | January 2009 |
Estimated Primary Completion Date | July 2011 |
Current Primary Outcome Measures | The change of HbA1c [Time Frame: 52 weeks] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination |
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Official Title | Predictive Parameters for Therapeutic Efficacy of Initial Combination Therapy With Sitagliptin and Metformin in Type 2 Diabetic Patients |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes |
Intervention | Drug: sitagliptin, metformin sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks. Other Names: Januvia |
Study Arm (s) | Experimental: Metformin+Sitagliptin Initial combination of metformin and sitagliptin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 150 |
Estimated Completion Date | July 2011 |
Estimated Primary Completion Date | June 2010 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00969566 |
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Other Study ID Numbers | SNUBH_ENDO1 |
Has Data Monitoring Committee | Yes |
Information Provided By | Seoul National University Bundang Hospital |
Study Sponsor | Seoul National University Bundang Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Soo Lim, MD, MPH, PHD Seoul National University Bundang Hospital |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Seoul National University Bundang Hospital | Seongnam, Gyeonggi, Korea, Republic of, 463-707 |
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