Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1. Commencing Metformin • Type 2 diabetes diagnosed more than 6 weeks prior to visit 1 • GP considers adequate diet and lifestyle advice given • Age >35 and 35 • White European • HbA1c >7% & =50 ml/min • ALT 35 and 35 • White European • HbA1c >7% & =50 ml/min • ALT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cohort 1. • Type 1 diabetes • HbA1c >9% or 2.5*ULN • Alcohol consumption in excess of 50 units per week • Female planning to conceive within the study period • Any other significant medical reason for exclusion as determined by the investigator Cohort 2. Randomised to second line therapy • Type 1 diabetes • HbA1c >9% or 2.5*ULN • Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure • Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide). • Previous diagnosis of osteoporosis • Pregnant female or female planning to conceive within the study period • Any other significant medical reason for exclusion as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To pilot recruitment strategies, uptake, feasibility, and ongoing follow up of a planned study to collect an incident cohort or patients treated with metformin, sitagliptin, pioglitazone and gliclazide MR. ;Secondary Objective: ;Primary end point(s): 1. HbA1c reduction at 6 months 2. Time to HbA1c >8% or new diabetes therapy | — |
Countries
United Kingdom
Outcome results
None listed