Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
NCT ID: NCT01862263
Last Updated: 2019-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
191 participants
INTERVENTIONAL
2013-05-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vildagliptin
Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day
Vildagliptin
Orally active and highly selective inhibitor of DPP-4
Insulin
Long- acting human insulin analog indicated to improve glycemic control
Placebo
Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)
Insulin
Long- acting human insulin analog indicated to improve glycemic control
Placebo
Matching placebo of vildagliptin
Interventions
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Vildagliptin
Orally active and highly selective inhibitor of DPP-4
Insulin
Long- acting human insulin analog indicated to improve glycemic control
Placebo
Matching placebo of vildagliptin
Eligibility Criteria
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Inclusion Criteria
2. Free will to sign the informed consent.
3. 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.
4. Type 2 diabetes mellitus
5. 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.
6. HbA1c between 7.5 to 9%.
7. Fasting plasma glucose (FPG) less than 270 mg/dL.
8. Body mass index (BMI) between 20 to 35 kg/m2.
9. Free willing to take the vildagliptin tablets during the study.
Exclusion Criteria
2. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
3. Acute cardiovascular complications or metabolic complications within the past 4 months.
4. History cerebrovascular disease during the last year.
5. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
6. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
7. Congestive heart failure requiring pharmacologic treatment.
8. Any known serious heart condition.
9. ALT and/or AST greater than three times the upper limit of the normal range.
10. Serum creatinine levels greater than 1.5 mg/dL
11. Malignancy including leukemia and lymphoma within the last 5 years
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Celaya, Guanajuato, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Cancún, Quintana Roo, Mexico
Novartis Investigative Site
Culiacán, Sinaloa, Mexico
Novartis Investigative Site
Metepec, State of Mexico, Mexico
Novartis Investigative Site
Puebla City, , Mexico
Countries
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Other Identifiers
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CLAF237AMX01
Identifier Type: -
Identifier Source: org_study_id
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