Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss

NCT02941445 | Completed Phase 4

• 1 other identifier: SITA after LIRA
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.

Conditions

Polycystic Ovary Syndrome; Body Weight

Keywords

DPP4-inhibitors

Outcome Measures

Primary Outcomes (1)

• Change in body weight.

  Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.

Secondary Outcomes (1)

• Change in body mass indey (BMI).

  Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.

Study Arms (2)

COMBO (sitagliptin and metformin)

EXPERIMENTAL

metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks

Drug: sitagliptin and metformin

MET (metformin)

EXPERIMENTAL

metformin 1000 mg BID

Drug: Metformin

Interventions

sitagliptin and metformin DRUG

Also known as: Janumet

COMBO (sitagliptin and metformin)

Metformin DRUG

Also known as: Glucophage

MET (metformin)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old to menopause
• polycystic ovary syndrome (NICHD criteria)
• BMI of 30kg/m2 or higher

You may not qualify if:

• type 1 or type 2 diabetes mellitus
• history of carcinoma
• Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
• personal or family history of multiple endocrine neoplasia type 2
• significant cardiovascular, kidney or hepatic disease
• the use of statins, within 90 days prior to study entry

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Body Weight

Interventions

Sitagliptin Phosphate; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Andrej Janež, MD PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share