Glucose absorption inhibitors given during insulin withdrawal in type 1 and type3c diabetes

Phase 4

Completed

• Conditions: Type 1 diabetes and Type 3c diabetes; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN16404006
• Lead Sponsor: niversity of Leicester

Brief Summary

2020 results in https://doi.org/10.2337/dc19-2579 (added 07/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-01
• Study Start: 2020-01-02
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities
2. Type 1 diabetes or type 3c (chronic pancreatitis or undergone pancreatic surgery) according to clinical judgment
3. Duration of type 1 or type 3c diabetes (chronic pancreatitis or undergone pancreatic surgery) greater than 12 months
4. Current treatment basal bolus insulin regime or insulin pump therapy
5. Aged 18 – 65 years
6. BMI of less than 35
7. HbA1c of greater or equal to 6.5% and less than 9%
8. Able and willing to complete the study
9. Patients who are or who have previously been involved in research are eligible provided they have not received an investigational drug within one month of entry into the study

Exclusion Criteria

1. Cannot adequately understand verbal and / or written explanations given in English
2. LADA –latent autoimmune diabetes in adults due to differing nature of the illness/Type 1
3. Confirmed excessive and compulsive drinking of alcohol i.e. alcohol abuse as determined from GP medical notes by the Fast Alcohol Screening Test (FAST) or history of previous alcohol abuse
4. Restricted food intake (e.g. on VLC diets) - as this depletes the person of calories and may affect your data. Consider excluding Individuals on a severe calorie restricted diet <800cals/day. Determined by history
5. Diagnosis of osteoporosis confirmed by DEXA scan
6. Proliferative retinopathy that has required acute treatment within last three months
7. Moderate to severe renal impairment (creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m²
8. History of unstable or rapidly progressing renal disease
9. Severe hepatic insufficiency / and or significant abnormal liver function defines as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) > 3ULN
10. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
11. Congestive heart failure defined as New York Heart Association (NYHA) class III and IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially:
11.1. Uncontrolled cardiac arrhythmias
11.2. Uncontrolled hypertension (BP greater than 160/90)
12. Mental incapacity
13. Pregnancy or breastfeeding women
14. Those of child-bearing potential not taking adequate contraception precautions. Adequate protection is defined as barrier protection, oral contraceptive pill or intrauterine device
15. Volume depleted patients, patients at risk of volume depleting due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
16. History of unstable angina.
17. Recent Cardiovascular Events in a patient:
17.1. Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
17.2. Hospitalisation for unstable angina or acute myocardial infarction within 2 months prior to enrolment
17.3. Acute Stroke or TIA within 2 months prior to enrolment
17.4. Less than 2 months post coronary artery revascularization
17.5. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. Accident and Emergency and/or hospitalisation) within 1 month prior to the Screening visit
18. Known or suspected allergy to study products
19. Known lactose-intolerant
20. Any other medical or psychological conditions that would interfere with the study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified