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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Exenatide 2 MG
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, GLP-1, GLP-1RA, exenatide, Metformin, glucagon-like peptide 1, glucagon-like peptide 1 receptor agonist

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Metformin

Metformin+EQW

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in body weight

Secondary Outcome Measures

Proportion of subjects who lost ≥5% of their body weight
Proportion of subjects who lost ≥ 10% of their body weight
Change in body mass index (BMI)
Change in waist circumference(WC)
Change in hip circumference (HC)
Changes in lipid accumulation product(LAP)
LAP=(WC(cm)-58)×TG (mmol/L)
Changes in Visceral obesity index(VAI)
VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))
Changes in blood pressure
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
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)
Changes in serum triglyceride (TG)
Changes in high-density lipoproteincholesterol (HDL-C)
Changes in low-density lipoproteincholesterol (LDL-C)
Changes in lipoprotein(a)
Changes in apolipoprotein a1(ApoA1)
Changes in apolipoprotein B(ApoB)
Changes in free fatty acid (FFA)
Changes in high sensitivity C reactive protein(hsCRP)
Frequency of menstrual cycle
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
Changes in Dehydroepiandrosterone sulfate (DHEAS)
Changes in Luteinizing Hormone (LH)
Changes in follicle stimulating hormone(FSH)
Changes in LH/FSH
Changes in Acne severity score
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
Changes in follicular number of 2-9mm in diameter

Full Information

First Posted
July 8, 2019
Last Updated
July 21, 2019
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04029272
Brief Title
Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2019 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, GLP-1, GLP-1RA, exenatide, Metformin, glucagon-like peptide 1, glucagon-like peptide 1 receptor agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Metformin+EQW
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
500 mg tid for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Exenatide 2 MG
Other Intervention Name(s)
Bydureon
Intervention Description
Exenatide injection once weekly for 12 weeks
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
Patient's body weight was measured at the baseline and after 12 weeks of clinical trial
Secondary Outcome Measure Information:
Title
Proportion of subjects who lost ≥5% of their body weight
Time Frame
12 weeks
Title
Proportion of subjects who lost ≥ 10% of their body weight
Time Frame
12 weeks
Title
Change in body mass index (BMI)
Time Frame
12 weeks
Title
Change in waist circumference(WC)
Time Frame
12 weeks
Title
Change in hip circumference (HC)
Time Frame
12 weeks
Title
Changes in lipid accumulation product(LAP)
Description
LAP=(WC(cm)-58)×TG (mmol/L)
Time Frame
12 weeks
Title
Changes in Visceral obesity index(VAI)
Description
VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))
Time Frame
12 weeks
Title
Changes in blood pressure
Time Frame
12 weeks
Title
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
Description
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)
Time Frame
12 weeks
Title
Changes in total cholesterol (TC)
Time Frame
12 weeks
Title
Changes in serum triglyceride (TG)
Time Frame
12 weeks
Title
Changes in high-density lipoproteincholesterol (HDL-C)
Time Frame
12 weeks
Title
Changes in low-density lipoproteincholesterol (LDL-C)
Time Frame
12 weeks
Title
Changes in lipoprotein(a)
Time Frame
12 weeks
Title
Changes in apolipoprotein a1(ApoA1)
Time Frame
12 weeks
Title
Changes in apolipoprotein B(ApoB)
Time Frame
12 weeks
Title
Changes in free fatty acid (FFA)
Time Frame
12 weeks
Title
Changes in high sensitivity C reactive protein(hsCRP)
Time Frame
12 weeks
Title
Frequency of menstrual cycle
Description
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.
Time Frame
12 weeks
Title
Changes in testosterone
Time Frame
12 weeks
Title
Changes in Dehydroepiandrosterone sulfate (DHEAS)
Time Frame
12 weeks
Title
Changes in Luteinizing Hormone (LH)
Time Frame
12 weeks
Title
Changes in follicle stimulating hormone(FSH)
Time Frame
12 weeks
Title
Changes in LH/FSH
Time Frame
12 weeks
Title
Changes in Acne severity score
Description
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)
Time Frame
12 weeks
Title
Changes in ovarian volume
Time Frame
12 weeks
Title
Changes in follicular number of 2-9mm in diameter
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Deng
Phone
13167559763
Email
yanndeng@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aiju Sun
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
1000730
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34732660
Citation
Ma RL, Deng Y, Wang YF, Zhu SY, Ding XS, Sun AJ. Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome. Chin Med J (Engl). 2021 Nov 3;134(23):2882-2889. doi: 10.1097/CM9.0000000000001712.
Results Reference
derived

Learn more about this trial

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

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