Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin dependent diabetes mellitus
Conditions
Interventions
1. Screening Visit:
At the 'screening visit' patients will attend in fasting state (due to C-peptide levels collection on this visit) and be asked to sign a consent form and data will be collected on
Sponsors
West Wales Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, Aged > 18 years In addition, patients should fulfil all the following criteria at the randomisation visit: 2. Type-1 Diabetic patients with C-peptide negative result at screening visit (defined as C-peptide concentration 5.0mmol/L) 3. Suboptimal glycaemic control (HbA1c 7.5% to 8.5% at screening visit) with or without history of mild hypoglycemia (defined as hypoglycemia not affecting cognitive function and not requiring third party intervention for reversal) 4. History of previous attempts to improve glycaemic control resulting in hypoglycemic episodes (history from hospital medical notes or directly from patients) 5. History of Diabetes for > 1 year 6. BMI 21 to 27 7. Willing and able to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Previous History of myocardial infarction (MI) (in last 12months) 2. Congestive Cardiac Failure (New York Heart Association [NYHA] class III or IV) 3. Chronic kidney disease with estimated Glomerular Filtration Rate (eGFR) 3fold at baseline) 5. Hypoglycaemia symptoms unawareness 6. History of hypoglycemic episodes requiring 3rd party assistance for reversal 7. Uncontrolled Hypertension (BP > 180/100mmHg) 8. Pregnant OR likelihood of pregnancy during the study 9. Females who are breast feeding 10. Proliferative Diabetic retinopathy and / or laser treatment in last 12 months 11. History of Diabetic ketoacidosis, lactic acidosis and gasteroparesis 12. Previous or current treatment with metformin / Glucophage® SR 13. History of irritable bowel syndrome. 14. Previous intolerance to metformin or Glucophage® SR 15. History of weight loss in last 6 months 16. History of allergic or hypersensitivity reaction to Glucophage® SR or any insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in glycaemic control as a result of addition of Glucophage® SR compared with placebo. Assessed by measurement of HbA1c at screening, baseline and 1, 2, 3, 4, 5 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in number of episodes of hypoglycemia in Glucophage® SR arm of study 2. Reduction in insulin dose in Glucophage® SR arm of the study All outcomes assessed at screening, baseline and 1, 2, 3, 4, 5 and 6 months. | — |
Countries
United Kingdom
Outcome results
None listed