Response to Oral Agents in Diabetes (ROAD) Pilot Study - ROAD study pilot

Conditions: Type 2 diabetes
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-004790-18-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 80
•Age of diabetes diagnosis >35
•White European
•HbA1c >7% & <=9%
•eGFR>=50 ml/min
•ALT <= 2.5*ULN
•Contactable by telephone

Cohort 2 - randomised to second line therapy
•Type 2 diabetes
•Treated with metformin for more than 3 months; or metformin intolerant
•Age >35 and < 80
•Age of diabetes diagnosis >35
•White European
•HbA1c >7% & <=9%
•eGFR>=50 ml/min
•ALT <= 2.5*ULN
•No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
•No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
•No osteoporosis
•Contactable by telephone

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

Exclusion Criteria

Cohort 1.
•Type 1 diabetes
•HbA1c >9% or <=7%
•eGFR<50 ml/min
•ALT > 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 <=7%
•eGFR< 50 ml/min
•ALT > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>2. Time to HbA1c >8% or new diabetes therapy

Secondary Outcome Measures