Trial Outcomes & Findings for The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS (NCT NCT03151005)

NCT ID: NCT03151005

Last Updated: 2023-12-04

Results Overview

Concentration of LH was measured in mIU/ml.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-12-04

Participant Flow

Participant milestones

Measure	Metformin-GLP-1 Receptor Agonist Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Overall Study STARTED	35	35
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Metformin-GLP-1 Receptor Agonist Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Overall Study Lost to Follow-up	5	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metformin-Oral Contraceptive(OC) n=30 Participants Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.	Metformin-GLP-1 Receptor Agonist n=30 Participants Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=30 Participants	3 Participants n=30 Participants	10 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=30 Participants	27 Participants n=30 Participants	50 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Continuous	22.43 years STANDARD_DEVIATION 5.30 • n=30 Participants	25.73 years STANDARD_DEVIATION 4.95 • n=30 Participants	24.08 years STANDARD_DEVIATION 5.35 • n=60 Participants
Sex: Female, Male Female	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Sex: Female, Male Male	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants
weight	70.98 kg STANDARD_DEVIATION 11.02 • n=30 Participants	73.95 kg STANDARD_DEVIATION 10.04 • n=30 Participants	72.47 kg STANDARD_DEVIATION 10.56 • n=60 Participants

PRIMARY outcome

Timeframe: 12 weeks

Concentration of LH was measured in mIU/ml.

Outcome measures

Measure	Metformin-GLP-1 Receptor Agonist n=30 Participants Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) n=30 Participants Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Assessment of Reproductive Functions	5.52 mIU/ml Standard Deviation 3.37	5.33 mIU/ml Standard Deviation 2.52

SECONDARY outcome

Timeframe: 12 weeks

Weight and height will be combined to report BMI in kg/m^2.

Outcome measures

Measure	Metformin-GLP-1 Receptor Agonist n=30 Participants Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) n=30 Participants Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Basic Vital Signs	26.26 kg/m^2 Standard Deviation 3.67	27.12 kg/m^2 Standard Deviation 4.04

SECONDARY outcome

Timeframe: 12 weeks

Alanine transaminase was measured in IU/L.

Outcome measures

Measure	Metformin-GLP-1 Receptor Agonist n=30 Participants Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) n=30 Participants Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Assessment of Liver Function	39.09 IU/L Standard Deviation 24.16	36.73 IU/L Standard Deviation 43.12

SECONDARY outcome

Timeframe: 12 weeks

Systolic blood pressure was measured in mmHg.

Outcome measures

Measure	Metformin-GLP-1 Receptor Agonist n=30 Participants Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) n=30 Participants Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Assessment of Blood Pressure	122.83 mmHg Standard Deviation 10.91	122.40 mmHg Standard Deviation 6.39

SECONDARY outcome

Timeframe: 12 weeks

Changes in testosterone levels were measured

Outcome measures

Measure	Metformin-GLP-1 Receptor Agonist n=30 Participants Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) n=30 Participants Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Assessment of Reproductive Function	1.82 nmol/L Standard Deviation 0.51	2.14 nmol/L Standard Deviation 1.02

Adverse Events

Metformin-GLP-1 Receptor Agonist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin-Oral Contraceptive(OC)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metformin-GLP-1 Receptor Agonist n=30 participants at risk Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.	Metformin-Oral Contraceptive(OC) n=30 participants at risk Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.
Hepatobiliary disorders Aminopherase elevation	0.00% 0/30 • 12 weeks	3.3% 1/30 • Number of events 1 • 12 weeks

Additional Information

Min Long, MD

Department of Endocrinology, Xinqiao Hospital, Army Military Medical University

Phone: 023-68763255

Email: longmin_casper@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place