Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Obesity

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Metformin

Glucagon

Glucagon-Like Peptide-1 Receptor Agonists

Glucagon-Like Peptide 1

Liraglutide

Biguanides

Incretins

Hormones

Hormone Antagonists

Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached

the patient is given Glucophage 1000 mg tab once daily after lunch for 1month

liraglutide

Sara A Salem, MD

Beni-Suef University

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:-

* Group1 (n=40) will be treated by liraglutide monotherapy.
* Group 2 (n=40) will be treated by metformin monotherapy.
* Group 3 (n=40) will be a control group.

To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment

* To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment
* Total Testosterone (TT)
* Dehydroepiandrosterone (DHEA)

To assess the clinical effect of the drugs, the following will be assessed before and after treatment:

The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome

basal body weight - body weight reached after treatment

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Musculoskeletal Diseases

Nervous System Diseases

Rare Diseases

Hyperglycemia

Acromegaly

ACTH-Secreting Pituitary Adenoma

Pituitary ACTH Hypersecretion

Adenoma

Pituitary Diseases

Metabolic Diseases

Glucose Metabolism Disorders

Bone Diseases

Bone Diseases, Endocrine

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pituitary Neoplasms

Endocrine Gland Neoplasms

ACTH-secreting Pituitary Adenoma

Anti-Infective Agents

Insulin

Insulin, Globin Zinc

Sitagliptin Phosphate

Pasireotide

Somatostatin

Dipeptidyl-Peptidase IV Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin.

Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.

This arm represents the non-randomized participants: Cushing's Disease (CD) or Acromegaly participants, who received pasireotide s.c. or LAR (long-acting release) respectively, but who were not randomized to the Incretin or Insulin arms.

For the purpose of analysis, this non-randomized arm is further split into 3 groups:

* Baseline insulin group (BL insulin) includes participants who were receiving insulin at study entry
* Oral antidiabetic drugs (OAD) group includes participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment
* No OAD group includes participants who did not receive any anti-diabetic medication during the core phase of the trial

Administered to Cushing's disease participants.

Pasireotide s.c.

Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective

Sitagliptin

Participant switched to liraglutide if sitagliptin was found not to be effective.

Participant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required.

Insulin was administered to the BL-insulin group at the discretion of the Principal Investigator.

Note: OAD and No OAD groups within the non-randomized arm did not take Insulin.

Pasireotide LAR

If previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator.

Note: No OAD group within the non-randomized arm did not take metformin.

Novartis Pharmaceuticals

The study was designed to investigate the optimal management of hyperglycemia developed during pasireotide treatment in participants with Cushing's disease or Acromegaly, which was not manageable with metformin.

This was a Phase IV, multi-center, randomized, open-label study. Eligible patients started pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for Acromegaly.

Participants being treated with pasireotide s.c or LAR at screening were eligible as long as they met protocol criteria during the screening period. If previously normo-glycemic participants experienced an increase in their fasting blood glucose and met the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to have elevated blood glucose above target on metformin within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.

Participants who continued to receive clinical benefit after completing the Core Phase could enter an optional Extension Phase if pasireotide was not commercially available in their country or a local access program was not available to provide drug. Patients continued in the Extension Phase until the last participant randomized in the Core Phase completed 16 weeks of treatment post-randomization.

Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Absolute change in HbA1c from randomization to end of core phase (16 weeks) in incretin based therapy arm and insulin arm, and mean difference of change in HbA1c between the two treatment groups based on an ANOVA model using treatment (Incretin, Insulin) and the two randomization stratification factors (Disease: Cushing's disease vs Acromegaly; Baseline glycemic status: HbA1c \<7% vs HbA1c ≥ 7%) as fixed effects. For Participants who discontinued the study or required rescue treatment before the time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.

Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm

Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm

The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized.

Absolute change in HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm

Absolute change in FPG from baseline to end of core phase in the incretin based therapy arm and the insulin arm.

Percentage of participants with ≤ 0.3% HbA1c increase in the incretin based therapy arm and the insulin arm.

There are different safety follow-up period for Cushing's and for acromegaly patients: On-treatment period: from day of first dose of study medication to 28 days after last dose of pasireotide s.c. and 84 days after last dose of pasireotide long acting, or the follow-up visit, whichever comes later.

Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin

Incretin Based Therapy (Randomized Group)

Insulin (Randomized Group)

This group included participants who were receiving insulin at study entry.

Baseline Insulin (BL) (Non-randomized Group)

This group included participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment. Patients in this group did not require additional treatment with either incretin or insulin.

Oral Antidiabetic Drugs (OAD) (Non-randomized Group)

This group included participants who did not receive any anti-diabetic medication during the Core Phase of the study as they did not develop hyperglycemia.

No OAD (Non-randomized Group)

Total

Age, Continuous

Sex: Female, Male

Other

Chinese

Hispanic/Latino

Indian (Indian subcontinent)

Japanese

Race/Ethnicity, Customized

Full Analysis Set (FAS): all participants who received at least one dose of pasireotide.

Study Director

All Patients

Cushing's Disease

Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.

If the patient discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.

Change in HbA1c From Randomization to Approximately 16 Weeks

Randomization

Change at RW4 D29

Change at RW8 D57

Change at RW12 D85

Change at RW16 D113

End of Core Phase

Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.

Change in HbA1c From Randomization (R) Over Time Per Randomized Arm

Change at RW2 D15

Change at RW6 D43

Change at RW10 D71

Change at RW14 D99

Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase

Safety set - All participants randomized to the incretin-based therapy who received at least one dose of pasireotide and had at least one post-baseline safety assessment. Randomized participants within the safety set were analyzed according to the anti-diabetic study treatment first received.

Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin

Baseline: All Patients

Change at EOP: All Patients

Baseline: Cushing's

Change at EOP: Cushing's

Baseline: Acromegaly

Change at EOP: Acromegaly

Full Analysis Set (FAS): Participants who received at least 1 dose of pasireotide. Randomized participants were analyzed according to the anti-diabetic treatment assigned to at randomization. Non-randomized participants were analyzed by the anti-diabetic treatment received during the core phase (insulin at baseline, oral antidiabetics (OAD), none).

Absolute Change in HbA1c From Baseline to End of Core Phase

Full Analysis Set (FAS): All participants who received at least one dose of pasireotide. Randomized patients were analyzed according to the anti-diabetic treatment assigned to at randomization. Non-randomized patients were analyzed by the anti-diabetic treatment received during the core phase (insulin at baseline, oral antidiabetics (OAD), none).

Absolute Change in FPG From Baseline to End of Core Phase

Randomized Analysis Set (RAS): all participants who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.

Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase

Core Phase

Extension Phase

Weight Loss

Infertility

Infertility, Female

Insulin Resistance

Body Weight

Overweight

Overnutrition

Nutrition Disorders

Body Weight Changes

Androgens

Metformin XR (extended-release) was initiated with a dose of 750 mg once per day for 2 week and increased to 1500 mg once per day for up to 12 weeks. Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), then titrated in increments of 0.6 mg once daily every 1 to 3 weeks to a final dose of 3.0 mg liraglutide SC daily for up to 12 weeks.

Metformin XR (extended-release) was initiated with a dose of 750 mg once per day for 2 week and increased to 1500 mg once per day for up to 12 weeks

Metformin XR (extended-release) was initiated at 750 mg once daily and increased to 1500 mg once daily after 2 week. Concomitantly, Liraglutide was initiated at a subcutaneous dose of 0.6 mg once daily for 1 week, then titrated in increments of 0.6 mg once daily every 1 to 3 weeks to a maintenance dose of 3.0 mg once daily for up to 12 weeks

Liraglutide + Metformin

Metformin XR (extended-release) was initiated at 750 mg once daily and increased to 1500 mg once daily after 2 week

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and one of the leading causes of infertility. PCOS and obesity affect up to 12.5% - 48.3% Asian women, increase incidence of impaired glucose tolerance, type 2 diabetes and aggravate insulin resistance, cause ovulatory dysfunction and menstrual disorders, and negatively impact outcomes of Assited Reproductive Technology (ART), with higher miscarriage rate when receiving ART. Weight loss decrease insulin resistance and hyperandrogenism, improve ovulation rate and menstrual cycle, significantly higher conception and live birth rates. Weight loss prior to IVF procedures has been associated with significantly improved pregnancy rates (PR) and live birth rates. Furthermore, a decreased number of IVF cycles required to achieve a pregnancy has also been reported after weight loss interventions. Based on the principles of fetal programming, improving a lifestyle before conception might lead to improved longterm health of the offspring. Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and metabolic - endocrine parameters and pregnancy rate in obese women diagnosed with PCOS are lacking. There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS).

The drug, liraglutide 3.0 mg was approved for chronic weight management in management in obese adults with an initial BMI of 30 kg/m2 or greater or in overweight adults BMI of 27 kg/m2 or greater with at least one weight-related co-morbid condition as an adjunct to a reduced-calorie diet and increased physical activity. Liraglutide is an acylated human glucagon-like peptide -1 (GLP-1) analog that binds to and activates the GLP-1 receptor. It lowers body weight through decreased caloric intake while stimulating insulin secretion and reducing glucagon via a glucose-dependent mechanism. For obesity management, patients may lose weight with GLP-1 receptor agonists due to other unique actions. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) can slow gastric emptying and increase satiety. While predictors of weight loss success for the general population are available (protein intake, weight loss medications), predictors of weight loss success may differ between normal and hyperandrogenic women. Glucagon-like peptide 1 agonists are linked with dose dependent weight lowering potential in different obesity related populations. The weight loss effects of GLP-1RAs previously demonstrated in diabetic and obese non-diabetic patients, offer a unique opportunity to expand the medical options available to patients with PCOS. Metformin was recommended for women with PCOS and obesity (BMI ≥ 25 kg/m2) or at metabolic risks and shown beneficial effects on menstrual disorders, anovulation, hyperandrogenism, and cardiovascular abnormalities.

The aim of this study was to evaluate the impact of liraglutide in combination with metformin compared to metformin alone on weight reduction, the multifaceted metabolic - endocrine disturbances, and oocyte and embryo quality, IVF PRs and cumulative PRs (IVF and spontaneous pregnancies) in infertile obese women with PCOS who had been previously poor responders to weight reduction with lifestyle modification.

Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility

Effectiveness of the Combination Liraglutide and Metformin on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With Polycystic Ovarian Syndrome, Obesity and Infertility

Treatment impact on change in body weight after 12 weeks of treatment.

Treatment effect on reducing body weight expressed as percent body weight loss from baseline

Treatment effect on loss of waist circumference (abdominal adiposity) with drug treatment

Change in central adiposity with treatment as measured by waist-to-hip ratio. A reduction in ratio indicates a decrease in truncal fat.

Treatment effect on loss of central adiposity as determined by Waist-to Height Ratio. The lower the ratio indicates less abdominal adiposity.

Treatment effect on reduction of fat mass (kg)

Treatment effect on reduction of percent body fat by BIA

Treatment effect on reduction of visceral fat level by BIA

Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)

Treatment effect on glucose measured at 120 minutes of an oral glucose tolerance test (OGTT)

Treatment effect on fasting insulin prior to an oral glucose tolerance test (OGTT)

Treatment effect on insulin measured at 120 minutes of an oral glucose tolerance test (OGTT)

Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant.

The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity

Treatment impact on improving total cholesterol levels

Impact of treatment on HDL levels after 12 weeks of treatment

Drug effect of TRG levels after treatment

Treatment impact on improving LDL-C after treatment

Treatment impact on systolic blood pressure

Treatment impact on reducing diastolic blood pressure

Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year.

Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic).

Drug treatment effect on total testosterone concentrations

Treatment efficacy in reducing adrenal hyperandrogenism

Treatment efficacy in reducing ovary volume

Treatment effect on spontaneous pregnancy rate

Treatment effect on Assisted Reproductive Therapy Pregnancy Rate

Treatment effect on Cumulative Pregnancy Rate

Drug treatment impact on total dosage GNT

Drug treatment impact on No. of retrieved oocytes/patient

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome	NCT05965908	Polycystic Ovar...	liraglutide Metformin	20 Years - 40 Years	Beni-Suef University
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly	NCT02060383	Cushing's Disea... Acromegaly	Pasireotide s.c... Sitagliptin Liraglutide Insulin Pasireotide LAR Metformin	18 Years -	Novartis
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly	NCT02060383	Cushing's Disea... Acromegaly	Pasireotide s.c... Sitagliptin Liraglutide Insulin Pasireotide LAR Metformin	18 Years -	Novartis
Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility	NCT05952882	Polycystic Ovar... Obesity Infertility, Fe...	Liraglutide + M... Metformin	18 Years - 65 Years	Mỹ Đức Hospital
Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin	NCT01911468	PCOS Obesity	metformin liraglutide metformin and l...	18 Years - 55 Years	University Medical Centre Ljubljana
Polycystic Ovary Syndrome and Liraglutide	NCT01899430	PCOS Obesity	liraglutide metformin	18 Years - 55 Years	University Medical Centre Ljubljana
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)	NCT01511393	Diabetes Diabetes Mellit... Medullary Thyro... Weight Manageme...	No treatment gi...	18 Years -	Novo Nordisk A/S

Spots Global Cancer Trial Database for liraglutide

Every month we try and update this database with for liraglutide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for liraglutide

Every month we try and update this database with for liraglutide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for liraglutide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.