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The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Active Comparator | In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. |
|
| combined | Active Comparator | In the metformin and liraglutide group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. At the same time liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
|
| |
| Glucophage tablets and Victoza |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | up to 12 weeks of clinical trial | |
| The number of good responders to combined treatment regarding body weight | up to 12 weeks of clinical trial |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI). | Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters. | up to 12 weeks of clinical trial |
| Change in waist circumference |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting concentrations of glucose | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. | up to 12 weeks of clinical trial |
| Change in fasting concentration of insulin |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069450 | Liraglutide |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D052216 |
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| Drug |
|
|
waist circumference was measured in centimeters.
| up to 12 weeks of clinical trial |
Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.
| up to 12 weeks of clinical trial |
| Change in blood concentrations of LH (luteinizing hormone) | Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L. | up to 12 weeks of clinical trial |
| Change in blood concentrations of FSH (follicle-stimulating hormone) | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L. | up to 12 weeks of clinical trial |
| Change in blood concentration of testosterone | Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L. | up to 12 weeks of clinical trial |
| Change in blood concentration in androstenedione | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L. | up to 12 weeks of clinical trial |
| Change in blood concentrations of SHBG (sex hormone-binding globulin) | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L. | up to 12 weeks of clinical trial |
| Change in blood concentration of DHEAS (dehydroepiandrosterone sulfate) | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L. | up to 12 weeks of clinical trial |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |