Status:
COMPLETED
Response To Oral Agents in Diabetes (ROAD)- Pilot Study
Lead Sponsor:
University of Dundee
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
36-79 years
Phase:
PHASE4
Brief Summary
This proposal is to fund a pilot study to assess feasibility and refine methodology for an intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study will collect coho...
Detailed Description
The Response to Oral Agents in Diabetes (ROAD) study aims to address the limitations of observational data by creating a prospective study of incident users of oral agents. For the first six months th...
Eligibility Criteria
Inclusion
- Cohort 1 - metformin treatment
- 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 - 2nd line treatment
- 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 diagnosis of osteoporosis
- Contactable by telephone
Exclusion
- 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
- Pregnancy, lactation or a female planning to conceive within the study period
- Any other significant medical reason for exclusion as determined by the investigator
- Cohort 2
- 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
- Pregnancy, lactation or a female planning to conceive within the study period
- Any other significant medical reason for exclusion as determined by the investigator
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00780715
Start Date
December 1 2008
End Date
October 1 2009
Last Update
October 26 2017
Active Locations (1)
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1
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY