- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00780715
Response To Oral Agents in Diabetes (ROAD)- Pilot Study (ROAD)
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 cohorts of patients who have carefully controlled standardised dose titration and monitoring with an assessment of drug response and side effects over a 6 month period. The primary aim will be to use these cohorts to investigate phenotypic and genotypic (pharmacogenetic) determinants of response.
Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin. With the ability to capture patient data beyond 6 months via data linkage we will monitor time to treatment failure and therefore compare which of the 3 oral agents is the best therapy to use after Metformin in a cost efficient and "real world" RCT.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Dundee, United Kingdom, DD1 9SY
- Ninewells Hospital & Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Gliclazide MR
|
30mg daily increased to 60mg if HbA1c > 7% at 3 months
Other Names:
|
ACTIVE_COMPARATOR: Sitagliptin
|
Sitagliptin 100mg daily for 6 months
|
ACTIVE_COMPARATOR: Pioglitazone
|
Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months.
6 months duration
Other Names:
|
EXPERIMENTAL: Metformin
|
Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after.
Total of 6 months treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c Change
Time Frame: 6 months
|
Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ewan R Pearson, University of Dundee
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Pioglitazone
- Sitagliptin Phosphate
- Gliclazide
Other Study ID Numbers
- 2008DM05
- EudraCT 2008-004790-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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