SIMPLANT

Phase 1

• Conditions: Recurrent miscarriage; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2016-001120-54-GB
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-01
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

- Provision of informed written consent
- History of recurrent miscarriage - 3 or more miscarriages, defined as three or more spontaneous pregnancy losses prior to 24 weeks gestation
- Age 18-42 years at consent
- Any BMI – no dose adjustment needed for BMI. BMI has no clinically meaningful effect on the pharmacokinetics of Sitagliptin.
- Willing and able to give consent for the study and endometrial biopsy.
- Ability to fully understand the requirements of the protocol
- Adequate renal function , defined as Urea 2.5 – 7.8mmol/L, Creatinine 50 -90umol/L, potassium 3.5 – 5.3mmol/L, Sodium 133 -146mmol/L
- Adequate hepatic function, defined as total protein 60 – 80g/L, Albumin 35-50g/L, Bilirubin 4-20umol/L, Alkaline Phosphatase (ALP) 35-105U/L, Alanine Transferase (ALT) 5-38 U/L
- Negative pregnancy test on the day of randomisation

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Under 18 years of age – the safety and effectiveness of Sitagliptin in paediatric patients under 18 has not yet been established.
- Type I Diabetes – Sitagliptin should not be used in type 1 diabetes
- Type II Diabetes – based on medical history
- Pregnancy: tested at multiple points in trial – see schedule of events
- Breast feeding – Caution is advised when prescribing Sitagliptin to breastfeeding mothers as it is not known if it is secreted in breast milk.
- Known hypersensitivity to Sitagliptin
- Not taking any medications with potential to react with the interventional product including Digoxin –plasma monitoring is needed if Sitagliptin used concomitantly in those at risk of digoxin toxicity, and Enalapril – Sitagliptin appears to alter the hypotensive effects of enalapril.
- Previous diagnosis of pancreatitis
- Renal impairment with eGFR<50 mL/min
- Liver impairment, defined as any value out of normal range (total protein 60 – 80g/L, Albumin 35-50g/L, Bilirubin 4-20umol/L, Alkaline Phosphatase (ALP) 35-105U/L, Alanine Transferase (ALT) 5-38 U/L)
- Inclusion in another intervention trial
- Unwilling to use effective contraception for the duration of the trial (from consent)
- Allergy/sensitivity to excipients of the IMP/placebo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified