GRAVITAS

Phase 1

• Conditions: TYPE 2 DIABETES MELLITUS; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003923-23-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-25
• Study Completion: 2018-08-08
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

•Male or female
•Aged between 18-70 years
•=12 months after gastric bypass or sleeve gastrectomy bariatric surgery
•Diagnosed with Type 2 diabetes mellitus according to WHO 2006 and 2011 criteria
•HbA1c >6.5% (>48 mmol/mol) on screening
•On Metformin ± long acting insulin
•Able to give informed consent
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Diagnosed with Type 1 diabetes mellitus
•Anatomical or endocrinological pathology causing poor weight loss or weight regain
•Screening calcitonin of 50 ng/L or above
•Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
•Personal history of non-familial medullary thyroid carcinoma
•History of acute or chronic pancreatitis
•Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
•Estimated glomerular filtration rate (eGFR) <30 ml/min • 1.73 m2).
•Current pregnancy.
•Inability to maintain adequate contraception.

Study & Design

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