Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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23 May 2016 |
Main ID: |
NCT02683226 |
Date of registration:
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11/02/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
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Scientific title:
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Date of first enrolment:
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March 2015 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02683226 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30 kg/m² or higher
Exclusion Criteria:
- type 1 or type 2 diabetes mellitus
- history of carcinoma
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- personal or family history of MEN 2
- significant cardiovascular, kidney or hepatic disease
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Polycystic Ovary Syndrome
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Intervention(s)
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Drug: Vipdomet
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Drug: Incresync
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Primary Outcome(s)
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Primary outcome was change in fasting concentration of glucose.
[Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.]
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Primary outcome was change in beta cell function using adaptation index.
[Time Frame: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.]
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Primary outcome was change in fasting concentration of insulin.
[Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.]
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The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
[Time Frame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.]
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Secondary Outcome(s)
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Secondary outcome was change in body mass index (BMI).
[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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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