Back to resultsComparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
Primary Purpose
Polycystic Ovary Syndrome, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Vipdomet
Incresync
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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
Sites / Locations
- University Medical Center Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
metformin and alogliptin
pioglitasone and alogliptin
Arm Description
Vipdomet 12.5 mg/1000 mg tablets
Incresync 12,5 mg/30 mg tablets
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02683226
First Posted
February 11, 2016
Last Updated
May 10, 2016
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT02683226
Brief Title
Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin and alogliptin
Arm Type
Experimental
Arm Description
Vipdomet 12.5 mg/1000 mg tablets
Arm Title
pioglitasone and alogliptin
Arm Type
Experimental
Arm Description
Incresync 12,5 mg/30 mg tablets
Intervention Type
Drug
Intervention Name(s)
Vipdomet
Intervention Type
Drug
Intervention Name(s)
Incresync
Primary Outcome Measure Information:
Title
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
Description
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.
Title
Primary outcome was change in beta cell function using adaptation index.
Description
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.
Title
Primary outcome was change in fasting concentration of glucose.
Description
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.
Title
Primary outcome was change in fasting concentration of insulin.
Description
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 Measure Information:
Title
Secondary outcome was change in body mass index (BMI).
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Medical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
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