Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344851
Status:
COMPLETED
Last Update Posted:
2007-07-11
First Post:
2006-06-23
Brief Title:
Exenatide and Metformin Therapy in Overweight Women With PCOS
Sponsor:
Metabolic Center of Louisiana Research Foundation
Organization:
Metabolic Center of Louisiana Research Foundation
Study Overview
Official Title:
Comparison of the Effects of Monotherapy With Exenatide or Metformin to Combined Exenatide and Metformin Therapy on Menstrual Cyclicity in Overweight Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia such as weight reduction and the administration of oral antidiabetic drugs in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles A new medicine called exenatide Byetta has been found to reduce body weight as well as improve abnormal glucose metabolism in diabetics This randomized study will compare Exenatide Byetta to extended release metformin Fortamet to combination therapy both Byetta and Fortamet on menstrual cyclicity hormone profiles and metabolic profiles over a 24-week period in women with PCOS
Detailed Description:
Objectives The objective of the present proposal is to compare the clinical endocrine and metabolic effects of therapy with exenatide and metformin alone to combination therapy in women with PCOS This study will serve as a pilot investigation to open perspectives for future investigations combining insulin-sensitizing drugs with different mechanisms of action in patients with PCOS especially ones for whom standard treatment with metformin is less effective
Subjects 60 oligomenorrheic overweightobese BMI 27 women meeting criteria for PCOS age 18-40 six or fewer menses year or amenorrheic clinical or laboratory evidence of hyperandrogenism hirsutism or elevated testosterone T PCOS ovary on ultrasoundneed to meet criteria 1 and either 2 or 3 or both InclusionExclusion Criteria Major EXCLUSION CRITERIA - FEMALE1 other uncorrected endocrinopathy- hyperprolactinemia hyper- or hypothyroidism congenital adrenal hyperplasia2 presence of overt diabetes or impaired glucose tolerance3 alterations in hepatic or renal function4 use of hormonal medications insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks5 Any medical condition which in the judgment of the investigator may interfere with the absorption distribution metabolism or excretion of the drug6 Simultaneous participation in another clinical trial7 Known active substance abuse including tobacco and alcohol 10 cigarettesday8 Refusal or inability to comply with protocol9 patient desiring pregnancy pregnant or breastfeeding Study Design Balanced randomized parallel group clinical study with 3 treatment arms metformin 1000 mg BID exenatide 10 mcg BID or combined metformin 1000 mg BID exenatide 10 mcg BID therapy for 24 weeks
Efficacy Measures Primary- Menstrual Cyclicity menses 24 weeksSecondary-BMI WHR FAI TSHBG DHEAS lipids insulin resistance-HOMA and composite insulin sensitivity index SIOGTT and pancreatic ß-cell function corrected insulin response CIRgp and insulinogenic index IGI
Safety For safety all subjects who enter the study are evaluable Subjects will be monitored for safety by assessment of adverse events physical exams vital signs and laboratory values
Statistical methodsanalysis The measurement of menstrual frequency involves nominal data patients withwithout regular cycles pre vs post-treatment and will be analyzed using the McNemar test complex chi square for paired data For all other analyses in which the data are interval parameters such as androgens lipids insulin sensitivity etc will be evaluated using a SSTreatment x Trials prepost analyses of variance ANOVA This repeated measures design will allow us to determine if each of the treatment drugs had an effect and if they are significantly different from each other while controlling for individual patient differences Study Drug Regimens Exenatide5 ug bid - 4 weeks10 ug bid - 20 weeks end of studyMetformin500 mg qd 2 weeks500 mg bid 2 weeks 500 mg am 1000 mg pm- 2 weeks1000 mg bid -18 weeks end study Exenatide plus MetforminExenatide- 5 ug bid-4 weeksMetformin 500 qd for 2 weeks 500 mg bid 2 weeksExenatide- 10 ug -20 weeks to end of studyMetformin-500 mg am 1000 mg pm- 2 weeks - 1000 bid for 18 weeks end of study Metformin may be adjusted at the discretion of the physician to a level that is tolerable in patients who cannot tolerate the full dose of metformin in combination with exenatide combination therapy only
Subjects 60 oligomenorrheic overweightobese BMI 27 women meeting criteria for PCOS age 18-40 six or fewer menses year or amenorrheic clinical or laboratory evidence of hyperandrogenism hirsutism or elevated testosterone T PCOS ovary on ultrasoundneed to meet criteria 1 and either 2 or 3 or both InclusionExclusion Criteria Major EXCLUSION CRITERIA - FEMALE1 other uncorrected endocrinopathy- hyperprolactinemia hyper- or hypothyroidism congenital adrenal hyperplasia2 presence of overt diabetes or impaired glucose tolerance3 alterations in hepatic or renal function4 use of hormonal medications insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks5 Any medical condition which in the judgment of the investigator may interfere with the absorption distribution metabolism or excretion of the drug6 Simultaneous participation in another clinical trial7 Known active substance abuse including tobacco and alcohol 10 cigarettesday8 Refusal or inability to comply with protocol9 patient desiring pregnancy pregnant or breastfeeding Study Design Balanced randomized parallel group clinical study with 3 treatment arms metformin 1000 mg BID exenatide 10 mcg BID or combined metformin 1000 mg BID exenatide 10 mcg BID therapy for 24 weeks
Efficacy Measures Primary- Menstrual Cyclicity menses 24 weeksSecondary-BMI WHR FAI TSHBG DHEAS lipids insulin resistance-HOMA and composite insulin sensitivity index SIOGTT and pancreatic ß-cell function corrected insulin response CIRgp and insulinogenic index IGI
Safety For safety all subjects who enter the study are evaluable Subjects will be monitored for safety by assessment of adverse events physical exams vital signs and laboratory values
Statistical methodsanalysis The measurement of menstrual frequency involves nominal data patients withwithout regular cycles pre vs post-treatment and will be analyzed using the McNemar test complex chi square for paired data For all other analyses in which the data are interval parameters such as androgens lipids insulin sensitivity etc will be evaluated using a SSTreatment x Trials prepost analyses of variance ANOVA This repeated measures design will allow us to determine if each of the treatment drugs had an effect and if they are significantly different from each other while controlling for individual patient differences Study Drug Regimens Exenatide5 ug bid - 4 weeks10 ug bid - 20 weeks end of studyMetformin500 mg qd 2 weeks500 mg bid 2 weeks 500 mg am 1000 mg pm- 2 weeks1000 mg bid -18 weeks end study Exenatide plus MetforminExenatide- 5 ug bid-4 weeksMetformin 500 qd for 2 weeks 500 mg bid 2 weeksExenatide- 10 ug -20 weeks to end of studyMetformin-500 mg am 1000 mg pm- 2 weeks - 1000 bid for 18 weeks end of study Metformin may be adjusted at the discretion of the physician to a level that is tolerable in patients who cannot tolerate the full dose of metformin in combination with exenatide combination therapy only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None