Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome

Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance IGT and Type 2 Diabetes T2D in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome PCOS

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03122041

Enrollment

Registered

2017-04-20

Start date

2016-08-31

Completion date

2016-11-30

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS

Keywords

metformin intolerance, PCOS, Sitagliptin, beta cell function

Brief summary

Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.

Interventions

DRUGSitagliptin

BEHAVIORALLifestyle intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* 18 years old to menopause * polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria) * BMI of 30 kg/m2 or higher

Exclusion criteria

* significant cardiovascular disease * significant kidney or hepatic disease * personal or family history of medullary thyroid carcinoma * known history of gallbladder disease * known history of pancreatitis

Design outcomes

Primary

Measure	Time frame
The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index).	Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial.

Secondary

Measure	Time frame
The secondary outcome was change in fasting plasma glucose level (G0)	Patient's fasting glucose level was measured at the base point and after 12 weeks of clinical trial.
The secondary outcome was change in plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT).	Patient's plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT) was measured at the base point and after 12 weeks of clinical trial.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026