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
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