Last Verified: | April/30/2020 |
First Submitted: | May/3/2020 |
Estimated Enrollment Submitted: | May/14/2020 |
First Posted: | May/18/2020 |
Last Update Submitted: | May/14/2020 |
Last Update Posted: | May/18/2020 |
Actual Study Start Date: | June/30/2020 |
Estimated Primary Completion Date: | July/19/2020 |
Estimated Study Completion Date: | December/19/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
: | single center single blind study |
Primary Purpose: | Treatment |
Masking: | Single (Investigator) |
Arm | Intervention/treatment |
---|---|
Active Comparator: metformin/alogliptin metformin/alogliptin (850 mg/12.5 mg or 1000 mg/12.5 mg every 12 hours) for 12 months | |
Active Comparator: metformin/pioglitazone metformin/pioglitazone (850 mg/15 mg every 12 hours) for 12 months | |
Active Comparator: triple therapy metformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months | Drug: triple therapy Metformin / Alogliptin/ Pioglitazone |
Ages Eligible for Study: | 35 Years to 35 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - DMT2 patients were enrolled in presence of 1. Age >35 and <75 years old 2. Uncontrolled diabetes during treatment (glycosylated hemoglobin (HbA1c) > 75 mmol/mol ) 3. Combined therapy at least by 6 months. Exclusion Criteria: 1. HbA1c < 75 mmol/mol (9%); 2. History of drug abuse or alcohol abuse, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day: 7 drinks per week) in the previous one year; 3. Estimated glomerular filtration rate (GFR) <30 ml/min (according to MDRD formula) 4. .Liver Failure 5. Recent history of Heart stroke, systemic infections, dehydration, lactic acidosis 6. Heart failure (NYHA I - IV) 7. Active bladder cancer or history of bladder cancer 8. macroscopic haematuria of unidentified nature 9. hypersensitivity to drug used (metformin, alogliptin, pioglitazone) 10. breastfeeding |