Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Information source: Pusan National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: vildagliptin (Drug); Pioglitazone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pusan National University Hospital Official(s) and/or principal investigator(s): In Ju Kim, MD, Principal Investigator, Affiliation: Pusan National University Hospital
Summary
The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin
to pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes
inadequately controlled with metformin monotherapy.
Clinical Details
Official title: An Open-label, Randomized, Active-controlled Study to Compare the Effect of 16 Weeks Treatment With Vildagliptin to Pioglitazone as add-on Therapy to Metformin in Type 2 Diabetic Patients Inadequately Controlled With Metformin Monotherapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group
Secondary outcome: To Compare Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin GroupsTo Compare Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups To Compare Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups To Compare Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Detailed description:
Type 2 diabetes mellitus (T2DM) is a chronic progressive disease characterized by
hyperglycemia that result from pancreatic islet dysfunction. Presently available oral
antihypoglycemic drug improves glycemic control over the short term, none has been shown to
stop the progressive decline in beta cell function which contributes to the deterioration of
glycemic control over time.
Pathophysiology of T2DM is known as tissue resistance for insulin and progressive beta cell
failure. Which one attributes first is unclear, but non-obese T2DM patients often show
normal fasting plasma glucose (FPG) but postprandial plasma glucose (PPG) level is high and
reduced or lacking normal compensatory insulin secretion. In Korea, more than 80% of T2DM
are non-obese type (BMI >= 27 ) and it was observed that basal insulin level and
compensatory insulin secretion reaction were reduced in normal healthy population. Based on
that, metformin is an established first line treatment for type 2 diabetes, acting primarily
to enhance hepatic and peripheral insulin sensitivity. However, it has become increasingly
apparent that many patients require a combination of agents to attain optimal glycemic
control.
Better understanding of incretin effect on the pathophysiology of T2DM has recently led to
development of new oral hypoglycemic agents. Vildagliptin is a potent and highly selective
dipeptidyl peptidase (DPP)-IV inhibitor that improves islet function by increasing
pancreatic alpha and beta cell responsiveness to glucose. Studies in patients with T2DM have
shown that vildagliptin significantly reduced HbA1c and FPG level from baseline and did not
induce weight gain and the incidence of hypoglycemia was low. In addition, studies in
rodents support an effort of vildagliptin on beta cell remodeling.
The thiazolidinediones are effective in reducing HbA1C in obese T2DM patients and it is
known that only thiazolidinedione can delay the beta cell failure . But recently,
thiazolidinediones were found to be associated with a decrease in bone mineral density and
to raise the risk of myocardial infarct and cardiovascular related mortality. Thus, there is
a need for new classes of blood glucose lowering drug which has the potential to delay or
prevent the progression of T2DM.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age in the range of 18 to 80 years
2. HbA1c 7 to 11%
3. FPG < 270 mg/dL (15 mmol/L);
4. Agreement to maintain prior diet & exercise
5. Written informed consent to participate in the study
Exclusion criteria:
1. Type 1 diabetes or Any kind of secondary diabetes
2. Pregnant or lactating women
3. Acute infections which may affect blood glucose control within 4 weeks prior to visit
1.
4. Significant diabetes complications e. g., symptomatic autonomic neuropathy or
gastroparesis
5. Previous history of severe cardiovascular disease such as
1. Torsades de Pointes, sustained and clinically relevant ventricular tachycardia,
or ventricular fibrillation
2. Percutaneous coronary intervention within the past 3 months
6. Any of the following within the past 6 months
1. Myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with
an MI and the date of the event cannot be determined, then the patient can enter
the study at the discretion of the investigator and the sponsor)
2. Coronary artery bypass surgery
3. Unstable angina
4. Stroke
7. Congestive heart failure (NYHA class I to IV)
8. Liver disease such as cirrhosis or chronic active hepatitis
9. Known sensitivity to pioglitazone, rosiglitazone, or similar drugs
10. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent
illness) within the past 6 months
11. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of
treatment) within 8 weeks prior to visit 1
12. Any of the following laboratory abnormalities
1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than
2. 5 times the upper limit of the normal range at visit 1
2. Direct bilirubin greater than 1. 3 times the upper limit of the normal range at
visit 1
3. Serum creatinine levels > 2. 5 mg/dL (220 μmol/L) at visit 1
4. Clinically significant thyroid-stimulating hormone (TSH) outside normal range at
visit 1
Locations and Contacts
Busan Saint Mary's Medical Center, Busan, Korea, Republic of
Dong-AUniversity Medical Center, Busan, Korea, Republic of
Inje University Baik Hospital, Busan, Korea, Republic of
Kosin University Hospital, Busan, Korea, Republic of
Pusan National University Hospital, Busan, Korea, Republic of
Changwon Fatima Hospital, Changwon, Korea, Republic of
Daegu Catholic University Medical Center, Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of
Kyungbuk National Universtiy Hospital, Daegu, Korea, Republic of
Chonnam National University Hospital, Gwangju, Korea, Republic of
Chosun University Hospital, Gwangju, Korea, Republic of
Chonbuk National University Hospital, Jeonju, Korea, Republic of
Gyeongsang National University Hospital, Jinju, Korea, Republic of
Masan Samsung Medical Center, Masan, Korea, Republic of
Ulsan University Hospital, Ulsan, Korea, Republic of
Additional Information
Starting date: December 2009
Last updated: March 4, 2015
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