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出境医 / 临床实验 / Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

Study Description
Brief Summary:
The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Exenatide 2 MG Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Metformin

Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)

Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.

 Drug: Metformin
500 mg tid for 12 weeks
Other Name: Glucophage
Experimental: Metformin+EQW

Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)

Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.

EQW: Participants will receive long-acting Exenatide once a week for 12 weeks

 Drug: Metformin
500 mg tid for 12 weeks
Other Name: Glucophage

Drug: Exenatide 2 MG
Exenatide injection once weekly for 12 weeks
Other Name: Bydureon
Outcome Measures
Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial ]

Secondary Outcome Measures :
  1. Proportion of subjects who lost ≥5% of their body weight [ Time Frame: 12 weeks ]
  2. Proportion of subjects who lost ≥ 10% of their body weight [ Time Frame: 12 weeks ]
  3. Change in body mass index (BMI) [ Time Frame: 12 weeks ]
  4. Change in waist circumference(WC) [ Time Frame: 12 weeks ]
  5. Change in hip circumference (HC) [ Time Frame: 12 weeks ]
  6. Changes in lipid accumulation product(LAP) [ Time Frame: 12 weeks ]
    LAP=(WC(cm)-58)×TG (mmol/L)

  7. Changes in Visceral obesity index(VAI) [ Time Frame: 12 weeks ]
    VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))

  8. Changes in blood pressure [ Time Frame: 12 weeks ]
  9. Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) [ Time Frame: 12 weeks ]

    glucose obtained at 0,30,60 and 120 minutes during the OGTT. HOMA-IR=Glu0(mmol/l)×Ins0(mU/ml)/22.5

    Matsuda index=1000/ square(Ins0 (mU/ml) ×Glu0 (mmol/l)×mean Glu(mmol/l)×meanIns(mU/ml)]

    QUICKI= 1/Log[Glu0 (mU/ml) ×Ins0 (mmol/l)]

    HOMA-β=20×Ins0 (mU/ml) /(Glu0 (mmol/l)-3.5)

    MBCI= Ins0 (mU/ml)×Glu0(mmol/l)／(Glu120(mmol/l)＋Glu60 (mmol/l)-2×Glu0 (mmol/l)）

    ΔI30/ΔG30 = (Ins30- Ins0)/( Glu30- Glu0)


  10. Changes in total cholesterol (TC) [ Time Frame: 12 weeks ]
  11. Changes in serum triglyceride (TG) [ Time Frame: 12 weeks ]
  12. Changes in high-density lipoproteincholesterol (HDL-C) [ Time Frame: 12 weeks ]
  13. Changes in low-density lipoproteincholesterol (LDL-C) [ Time Frame: 12 weeks ]
  14. Changes in lipoprotein(a) [ Time Frame: 12 weeks ]
  15. Changes in apolipoprotein a1(ApoA1) [ Time Frame: 12 weeks ]
  16. Changes in apolipoprotein B(ApoB) [ Time Frame: 12 weeks ]
  17. Changes in free fatty acid (FFA) [ Time Frame: 12 weeks ]
  18. Changes in high sensitivity C reactive protein(hsCRP) [ Time Frame: 12 weeks ]
  19. Frequency of menstrual cycle [ Time Frame: 12 weeks ]
    The number of menstrual cycles during the previous year was recorded and the menstrual cycle ratio calculated by dividing 12 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 12 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 3 by the number of menstrual cycles recorded in each patient's menstrual cycle diary.

  20. Changes in testosterone [ Time Frame: 12 weeks ]
  21. Changes in Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 12 weeks ]
  22. Changes in Luteinizing Hormone (LH) [ Time Frame: 12 weeks ]
  23. Changes in follicle stimulating hormone(FSH) [ Time Frame: 12 weeks ]
  24. Changes in LH/FSH [ Time Frame: 12 weeks ]
  25. Changes in Acne severity score [ Time Frame: 12 weeks ]
    This system divides the face, chest, and upper back into 6 areas: the forehead, right cheek,left cheek, nose, chin, and torso (chest and upper back combined). Each acne lesion is described and scored as a comedo (1 point), papule (2 points), pustule (3 points), or nodule (4 points); absence of an acne lesion in an area results in a score of 0 points. The local score for each anatomic area is determined by multiplying the score of the most severe lesion by an area factor (1 to 3), and the local scores of the 6 areas are then added together to obtain the total score. Acne severity is graded as none (total score, 0 points), mild (total score, 1-18 points), moderate (total score, 19-30 points), severe (total score, 31-38 points), and very severe (total score N38 points)

  26. Changes in ovarian volume [ Time Frame: 12 weeks ]
  27. Changes in follicular number of 2-9mm in diameter [ Time Frame: 12 weeks ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females 18 years to 40 years of age
  • Diagnosed as PCOS by the 2003 Rotterdam criteria.
  • Overweight/obesity (BMI≥25 kg/m2)
  • No pregnant plan in recent 6 months
  • Written consent for participation in the study

Exclusion Criteria:

  • type 1 or type 2 diabetes mellitus
  • Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
  • Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Serious systemic disease or malignant tumor
  • History of pancreatitis (chronic, acute or recurrent)
  • Body weight change ≥10% at 3 months before treatment
  • Used oral contraceptives or sex hormone drugs in the past 1 month
  • Used oral glucocorticoids in the past 1 month
  • Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
  • Subjects have a severe systemic disease, such as cardiovascular system
  • Renal impairment, eGFR<60ml/min/1.73m2
  • Increase of transaminases up to < 2.5 times of upper limit of normal value
  • Have a history of thromboembolic disease or thrombotic tendency
  • Subjects in pregnant or lactating or within 1 year after delivery.
  • Subjects have an allergic history to the drugs used in the study
  • Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
  • Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yan Deng 13167559763 yanndeng@163.com
Contact: Aiju Sun

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 1000730
Sponsors and Collaborators
Peking Union Medical College Hospital
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE July 20, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2019) 		Change in body weight [ Time Frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2019)
  • Proportion of subjects who lost ≥5% of their body weight [ Time Frame: 12 weeks ]
  • Proportion of subjects who lost ≥ 10% of their body weight [ Time Frame: 12 weeks ]
  • Change in body mass index (BMI) [ Time Frame: 12 weeks ]
  • Change in waist circumference(WC) [ Time Frame: 12 weeks ]
  • Change in hip circumference (HC) [ Time Frame: 12 weeks ]
  • Changes in lipid accumulation product(LAP) [ Time Frame: 12 weeks ]
    LAP=(WC(cm)-58)×TG (mmol/L)
  • Changes in Visceral obesity index(VAI) [ Time Frame: 12 weeks ]
    VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))
  • Changes in blood pressure [ Time Frame: 12 weeks ]
  • Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) [ Time Frame: 12 weeks ]
    glucose obtained at 0,30,60 and 120 minutes during the OGTT. HOMA-IR=Glu0(mmol/l)×Ins0(mU/ml)/22.5 Matsuda index=1000/ square(Ins0 (mU/ml) ×Glu0 (mmol/l)×mean Glu(mmol/l)×meanIns(mU/ml)] QUICKI= 1/Log[Glu0 (mU/ml) ×Ins0 (mmol/l)] HOMA-β=20×Ins0 (mU/ml) /(Glu0 (mmol/l)-3.5) MBCI= Ins0 (mU/ml)×Glu0(mmol/l)／(Glu120(mmol/l)＋Glu60 (mmol/l)-2×Glu0 (mmol/l)） ΔI30/ΔG30 = (Ins30- Ins0)/( Glu30- Glu0)
  • Changes in total cholesterol (TC) [ Time Frame: 12 weeks ]
  • Changes in serum triglyceride (TG) [ Time Frame: 12 weeks ]
  • Changes in high-density lipoproteincholesterol (HDL-C) [ Time Frame: 12 weeks ]
  • Changes in low-density lipoproteincholesterol (LDL-C) [ Time Frame: 12 weeks ]
  • Changes in lipoprotein(a) [ Time Frame: 12 weeks ]
  • Changes in apolipoprotein a1(ApoA1) [ Time Frame: 12 weeks ]
  • Changes in apolipoprotein B(ApoB) [ Time Frame: 12 weeks ]
  • Changes in free fatty acid (FFA) [ Time Frame: 12 weeks ]
  • Changes in high sensitivity C reactive protein(hsCRP) [ Time Frame: 12 weeks ]
  • Frequency of menstrual cycle [ Time Frame: 12 weeks ]
    The number of menstrual cycles during the previous year was recorded and the menstrual cycle ratio calculated by dividing 12 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 12 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 3 by the number of menstrual cycles recorded in each patient's menstrual cycle diary.
  • Changes in testosterone [ Time Frame: 12 weeks ]
  • Changes in Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 12 weeks ]
  • Changes in Luteinizing Hormone (LH) [ Time Frame: 12 weeks ]
  • Changes in follicle stimulating hormone(FSH) [ Time Frame: 12 weeks ]
  • Changes in LH/FSH [ Time Frame: 12 weeks ]
  • Changes in Acne severity score [ Time Frame: 12 weeks ]
    This system divides the face, chest, and upper back into 6 areas: the forehead, right cheek,left cheek, nose, chin, and torso (chest and upper back combined). Each acne lesion is described and scored as a comedo (1 point), papule (2 points), pustule (3 points), or nodule (4 points); absence of an acne lesion in an area results in a score of 0 points. The local score for each anatomic area is determined by multiplying the score of the most severe lesion by an area factor (1 to 3), and the local scores of the 6 areas are then added together to obtain the total score. Acne severity is graded as none (total score, 0 points), mild (total score, 1-18 points), moderate (total score, 19-30 points), severe (total score, 31-38 points), and very severe (total score N38 points)
  • Changes in ovarian volume [ Time Frame: 12 weeks ]
  • Changes in follicular number of 2-9mm in diameter [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
Official Title  ICMJE Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)
Brief Summary The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Metformin
    500 mg tid for 12 weeks
    Other Name: Glucophage
  • Drug: Exenatide 2 MG
    Exenatide injection once weekly for 12 weeks
    Other Name: Bydureon
Study Arms  ICMJE
  • Active Comparator: Metformin

    Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)

    Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.

    Intervention: Drug: Metformin
  • Experimental: Metformin+EQW

    Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months)

    Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.

    EQW: Participants will receive long-acting Exenatide once a week for 12 weeks

    Interventions:
    • Drug: Metformin
    • Drug: Exenatide 2 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females 18 years to 40 years of age
  • Diagnosed as PCOS by the 2003 Rotterdam criteria.
  • Overweight/obesity (BMI≥25 kg/m2)
  • No pregnant plan in recent 6 months
  • Written consent for participation in the study

Exclusion Criteria:

  • type 1 or type 2 diabetes mellitus
  • Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
  • Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Serious systemic disease or malignant tumor
  • History of pancreatitis (chronic, acute or recurrent)
  • Body weight change ≥10% at 3 months before treatment
  • Used oral contraceptives or sex hormone drugs in the past 1 month
  • Used oral glucocorticoids in the past 1 month
  • Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
  • Subjects have a severe systemic disease, such as cardiovascular system
  • Renal impairment, eGFR<60ml/min/1.73m2
  • Increase of transaminases up to < 2.5 times of upper limit of normal value
  • Have a history of thromboembolic disease or thrombotic tendency
  • Subjects in pregnant or lactating or within 1 year after delivery.
  • Subjects have an allergic history to the drugs used in the study
  • Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
  • Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yan Deng 13167559763 yanndeng@163.com
Contact: Aiju Sun
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029272
Other Study ID Numbers  ICMJE PCOS201907
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aijun Sun, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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