CANA/Met in Non-diabetic Women With PCOS

Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome

Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia, hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel glucose-lowering medication, have been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events in individuals with diabetes mellitus. However, evidences related to its management in non-diabetic PCOS women are limited. Hence, we want to give canangliflozin combined with metformin to women with PCOS to see its effect on insulin resistance.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Canagliflozin combined with metformin; Drug: metformin

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female aged 18- 45 years old;
2. Diagnosed criteria meet the Rotterdam criteria (2003);
3. Insulin Resistance

Exclusion Criteria:

1. Women who are pregnant or have a pregnancy plan within six months;
2. Confirmed diagnosis of diabetes.
3. Congenital adrenocortical hyperplasia;
4. Hyperprolactinemia;
5. Hyperthyroidism or hypothyroidism;
6. Combined with liver or kidney diseases;
7. Abnormal liver function (≥ 3 times of the upper limit of normal range);
8. Abnormal renal function (GFR<60ml/min/1.73m2);
9. Adrenal or ovarian tumors secreting androgens;
10. Used metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Canagliflozin/metformin group; Intervention with canagliflozin combined with metformin for three months	Drug: Canagliflozin combined with metformin; Canagliflozin, a novel glucose-lowering medication, has been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events. Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.
Active Comparator: Active Comparator: Metformin group; Intervention with metformin for three months	Drug: metformin; Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Changes in body mass index (BMI)	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total testosterone	Changes in total testosterone (TT)	Three months
Androstenedione	Changes in androstenedione (AND)	Three months
Dehydroepiandrosterone sulfate	Changes in dehydroepiandrosterone sulfate (DHEA-S)	Three months
Sex hormone-binding globulin	Changes in sex hormone-binding globulin (SHBG)	Three months

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Publications and helpful links

General Publications

• Zhang J, Xing C, Cheng X, He B. Canagliflozin combined with metformin versus metformin monotherapy for endocrine and metabolic profiles in overweight and obese women with polycystic ovary syndrome: A single-center, open-labeled prospective randomized controlled trial. Front Endocrinol (Lausanne). 2022 Sep 6;13:1003238. doi: 10.3389/fendo.2022.1003238. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): July 8, 2021
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Canagliflozin
• Other Study ID Numbers: 777

Drug and device information, study documents

• 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