Status:
TERMINATED
Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent read and signed before any protocol procedure.
- Free will to sign the informed consent.
- Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
- Type 2 diabetes mellitus
- Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
- HbA1c between 7.5 to 9%.
- Fasting plasma glucose (FPG) less than 270 mg/dL.
- Body mass index (BMI) between 20 to 35 kg/m2.
- Free willing to take the vildagliptin tablets during the study.
- Exclusion Criteria
- Pregnant or lactating female or without birth control method if of childbearing potential.
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
- Acute cardiovascular complications or metabolic complications within the past 4 months.
- History cerebrovascular disease during the last year.
- History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
- Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
- Congestive heart failure requiring pharmacologic treatment.
- Any known serious heart condition.
- ALT and/or AST greater than three times the upper limit of the normal range.
- Serum creatinine levels greater than 1.5 mg/dL
- Malignancy including leukemia and lymphoma within the last 5 years
- Other inlcusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01862263
Start Date
May 1 2013
End Date
July 1 2015
Last Update
June 5 2019
Active Locations (13)
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1
Novartis Investigative Site
Celaya, Guanajuato, Mexico, 38000
2
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44150
3
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44600
4
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44670