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Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination

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, metformin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Bundang Hospital

Official(s) and/or principal investigator(s):
Soo Lim, MD, MPH, PHD, Principal Investigator, Affiliation: Seoul National University Bundang Hospital

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.

Clinical Details

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

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

Primary outcome: The change of HbA1c

Secondary outcome:

Fasting Plasma Glucose (FPG)

Postprandial Plasma Glucose (PPG)

C-peptide

Glucagon

Homeostatic model assessment of insulin resistance (HOMA-IR)

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Seoul National University Bundang Hospital, Seongnam, Gyeonggi 463-707, Korea, Republic of
Additional Information

Starting date: January 2009
Last updated: January 5, 2012

Page last updated: August 23, 2015

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