NCT02683226|CompletedPhase 4
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Sponsor study identifier
interventional
30
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
July 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)July 2015
Actual (reported)February 11, 2016
Actual (reported)February 17, 2016
Actual (reported)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.
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.
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.
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.
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 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
Vipdomet 12.5 mg/1000 mg tablets
Incresync 12,5 mg/30 mg tablets
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Medical Center Ljubljana
Ljubljana, 1000, Slovenia
30 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2016
First Posted
February 17, 2016
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of OCP and Metformin on Clinical, Hormonal, Metabolic and Ultrasonographic Characteristics in PCOS
Contact the study team to confirm eligibility.
Primary Completion
June 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
May 11, 2016
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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