A Phase 4 interventional study of Vipdomet and Incresync in Polycystic Ovary Syndrome and Insulin Resistance, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-05-11.
Sponsored by University Medical Centre Ljubljana · Phase 4, Interventional, and Treatment
The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
Vipdomet 12.5 mg/1000 mg tablets
Drug: Vipdomet
Incresync 12,5 mg/30 mg tablets
Drug: Incresync
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.
Time frame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
Primary outcome was change in beta cell function using adaptation index.
Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.
Time frame: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
Primary outcome was change in fasting concentration of glucose.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Time frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Primary outcome was change in fasting concentration of insulin.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.
Time frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Secondary outcome was change in body mass index (BMI).
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
Time frame: Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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University Medical Centre Ljubljana