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Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS

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ClinicalTrials.gov Identifier: NCT02683226
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Drug: Vipdomet Drug: Incresync Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alogliptin

Arm Intervention/treatment
Experimental: metformin and alogliptin
Vipdomet 12.5 mg/1000 mg tablets
Drug: Vipdomet
Experimental: pioglitasone and alogliptin
Incresync 12,5 mg/30 mg tablets
Drug: Incresync



Primary Outcome Measures :
  1. 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. ]
    HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.

  2. 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. ]
    Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.

  3. 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. ]
    Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

  4. 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. ]
    Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.


Secondary Outcome Measures :
  1. 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 ]
    Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683226


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

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Responsible Party: Andrej Janez, Andrej Janez, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02683226     History of Changes
Other Study ID Numbers: MTT
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: February 2015

Additional relevant MeSH terms:
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Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action