A 5-YEAR STUDY TO COMPARE THE DURABILITY OF GLYCEMIC CONTROL OF A COMBINATION REGIMEN WITH VILDAGLIPTIN & METFORMIN VERSUS STANDARD-OF-CARE MONOTHERAPY WITH METFORMIN, INITIATED IN TREATMENT-NAIVE PATIENTS WITH TYPE 2 DIABETES MELLITUS
- Registration Number
- PER-048-12
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 59
1. WRITTEN INFORMED CONSENT MUST BE OBTAINED BEFORE ANY ASSESSMENT IS PERFORMED.
2. CONFIRMED DIAGNOSIS OF T2DM BY STANDARD CRITERIA.
3. T2DM DIAGNOSED ≤ 24 MONTHS AGO.
4. HBA1C ≥ 6.5% AND ≤ 7.5% AT VISIT 1.
5. PATIENTS WHO ARE TREATMENT-NAIVE, DEFINED IN THIS PROTOCOL AS:
• PATIENTS NOT HAVING EVER RECEIVED ANY ANTI-DIABETIC MEDICATION.
• PATIENTS WHO, AFTER THE DIAGNOSIS OF T2DM ≤ 24 MONTHS AGO, HAVE RECEIVED ANTIDIABETIC MEDICATION CUMULATIVELY FOR NOT MORE THAN 3 MONTHS, AND HAVE NOT RECEIVED ANY ANTI-DIABETIC TREATMENT WITHIN 3 MONTHS PRIOR TO VISIT 1 (ONLY METFORMIN ≤ 2000 MG DAILY IS ALLOWED WITHIN 1 MONTH PRIOR TO VISIT 1), SEE ALSO SECTION 4.2.
• PATIENTS WHO INITIATED METFORMIN WITHIN 1 MONTH PRIOR TO VISIT 1 AND TAKE A TOTAL DAILY DOSE OF MAXIMUM 2000 MG METFORMIN AT VISIT 1.
6. AGE ≥ 18 AND ≤ 70 YEARS OLD AT VISIT 1.
7. BODY MASS INDEX (BMI) ≥ 22 AND ≤ 4O KG/M2 AT VISIT 1.
8. WOMEN OF CHILD-BEARING POTENTIAL, DEFINED AS AH WOMEN PHYSIOLOGICAHY CAPABLE OF BECOMING PREGNANT, MUST USE EFFECTIVE METHODS OF CONTRACEPTION DURING DOSING OF STUDY TREATMENT
1. PREGNANT OR NURSING (LACTATING) WOMEN, WHERE PREGNANCY IS DEFINED AS THE STATE OF A FEMALE AFTER CONCEPTION AND UNTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE HUMAN CHORIONIC GONADOTROPIN (HCG) LABORATORY TEST.
2. USE OF ANY OFTHE FOLLOWING MEDICATIONS AS ASSESSED AT VISIT 1:
A. ANY ANTI-DIABETIC TREATMENT WITHIN 3 MONTHS PRIOR TO VISIT 1 (EXCEPT FOR METFORMIN WHICH IS ALLOWED WITHIN 1 MONTH PRIOR TO VISIT 1, SEE SECTION 3.1 AND SECTION 4.1) AND ANY ANTI-DIABETIC TREATMENT FOR MORE THAN 3 CONSECUTIVE MONTHS OR ADDING UP TO A TOTAL OF MORE THAN 3 MONTHS IN THE LAST 2 YEARS.
B. USE OF WEIGHT CONTROL PRODUCTS INCLUDING WEIGHT-LOSS MEDICATIONS IN THE PREVIOUS 3 MONTHS.
C. CHRONIC ORAL (>7 CONSECUTIVE DAYS), PARENTERAL OR INTRA-ARTICULAR CORTICOSTEROID TREATMENT WITHIN 8 WEEKS PRIOR TO VISIT 1.
D. TREATMENT WITH GROWTH HORMONE WITHIN THE PREVIOUS 6 MONTHS.
E. TREATMENT WITH ANY DRUG OR USE OF HERBAL MEDICINE OFKNOWN AND FREQUENT TOXICITY TO A MAJOR ORGAN, OR THAT MAY INTERFERE WITH THE INTERPRETATION OFTHE EFFICACY AND SAFETY DATA DURING THE STUDY.
3. A HISTORY OR EVIDENCE OF ANY OF THE FOLLOWING:
A. ACUTE METABOLIC CONDITIONS SUCH A KETOACIDOSIS, LACTIC ACIDOSIS OR HYPEROSMOLAR STATE (INCLUDING COMA) WITHIN THE PAST 6 MONTHS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method