A Phase 4 interventional study of titration and titration in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 4 sites in Korea, Republic of. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-18.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
Rationale Rosiglitazone and troglitazone both promote differentiation of pre-adipocytes into adipocytes in subcutaneous, but not omental fat, and reduce gamma glutamyl transferase, a surrogate marker for intra-abdominal and hepatic fat. Troglitazone has been shown by abdominal computed tomography (CT) and magnetic resonance imaging (MRI) scan to reduce the intra-abdominal adipose tissue area in type 2 diabetics. Similarly rosiglitazone has also been shown to increase subcutaneous but not intra-abdominal fat in patients with type 2 diabetes. In the same study it was also shown to cause a substantial reduction in hepatic fat. Central fat depots are believed to be associated with more cardiovascular risk than subcutaneous fat depots. By contrast, sulphonylurea-associated weight gain has been shown by abdominal CT scan to include increases in intra-abdominal adipose tissue.
The aim of this study is to compare the body fat distribution pattern of glibenclamide plus rosiglitazone versus glibenclamide and placebo (especially the intra-abdominal adipose tissue and abdominal subcutaneous adipose tissue areas) in patients with type 2 diabetes. It is hypothesised that rosiglitazone will lead to the accumulation of excess energy stores in the subcutaneous rather than the intra-abdominal adipose tissue depot. In addition, it is hoped that by having a positive effect on diastolic blood pressure, lipid levels, BMI, rosiglitazone will be shown to have a better cardiovascular risk profile when used in combination with glibenclamide rather than when glibenclamide is used alone.
Although insulin resistance has been shown to be a primary defect causing type 2 diabetes mellitus, insulin secretory defect has also been known to be an important factor in the development of type 2 diabetes mellitus. A previous study has shown that in Korean patients, early-phase insulin secretory defect may be the initial abnormality in the development of type 2 diabetes mellitus [56].
This study also aims to assess the efficacy and safety of glibenclamide plus rosiglitazone versus glibenclamide plus placebo therapy in Korean patients with type 2 diabetes. In addition, a previous study has shown that in Korean patients, early-phase insulin secretory defect may be the initial abnormality in the development of type 2 diabetes mellitus. This study aims to show that rosiglitazone treatment in Korean patients, regardless of their early phase insulin secretory ability, is just as efficacious and safe.
Objective(s) Primary To evaluate the effect of 12 months oral treatment with glibenclamide plus rosiglitazone versus oral glibenclamide plus placebo, on body fat distribution (as measured by the change in the ratio between the intra-abdominal adipose tissue and abdominal subcutaneous adipose tissue areas) in patients with type 2 diabetes.
Secondary
Endpoint(s) Primary Change from baseline in the ratio (IAAT:SAT) between the intra-abdominal adipose tissue area (IAAT) and abdominal subcutaneous adipose tissue area [SAT] after 12 months treatment with oral glibenclamide plus rosiglitazone compared to oral glibenclamide plus placebo Secondary
Comparisons will be made between glibenclamide plus rosiglitazone and glibenclamide plus placebo treatment groups on Change from baseline after 6 and 12 months treatment with respect the following:
CT Scan
Derived from CT image at the lumbar IV level:
Derived from the CT image of the right leg at the thigh level (1cm below the gluteal fold):
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Subjects were selected by following considerations:
glibenclamide plus rosiglitazone
Drug: titration
Drug: titration
Patients in the glibenclamide plus placebo treatment group Patients in the glibenclamide plus placebo treatment group who have FPG \< 270mg/dL after the glibenclamide 5mg om run-in will continue to receive glibenclamide 5mg om. At every subsequent visit, the glibenclamide dose will be titrated to achieve the target HbA1c level of \< 7%. If the HbA1c is \> 7%, the dose of glibenclamide will be escalated in the following sequence: from 5mg om, to 5mg om, 2.5mg on, to 5mg bd and 7.5mg om, 5mg on, to 7.5mg bd. The maximum total daily dose will not exceed 15 mg. A downward titration of glibenclamide using the above sequence in the reverse order can be used to maintain normoglycemia at any visit. Once the target HbA1c level of \< 7% is achieved, the dose of glibenclamide is maintained. If at the glibenclamide dose of 7.5mg bd, the HbA1c is \> 7% for 2 subsequent visits, the patient will be withdrawn from the study.
Patients in the glibenclamide + rosiglitazone treatment group who have FPG \< 270mg/dL after the glibenclamide 5mg om run-in will receive glibenclamide 5mg om + rosiglitazone 4mg om. At every subsequent visit, the glibenclamide dose will be titrated to achieve the target HbA1c level of \< 7%. If the HbA1c is \> 7%, the dose of glibenclamide will be escalated in a similar fashion as above. The only exception is at visit 5 when the dose of rosiglitazone is increased (see next paragraph). Once the target HbA1c level of \< 7% is achieved, the dose of glibenclamide is maintained. If at the glibenclamide dose of 7.5mg bd, the HbA1c is \> 7% for 2 subsequent visits, the patient will be withdrawn from the study.
Change from baseline in the ratio (IAAT:SAT) between the intra-abdominal adipose tissue area (IAAT) and abdominal subcutaneous adipose tissue area [SAT] after 12 months treatment with oral glibenclamide plus rosiglitazone compared to oral glibenclamide p
Time frame: baseline
Comparisons will be made between glibenclamide plus rosiglitazone and glibenclamide plus placebo treatment groups on Change from baseline after 6 and 12 months treatment with respect the following
Time frame: baseline
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