The National Diabetes Center

The National Diabetes Center©

Clinical Research

(Large scale simple trials)

Study #99-01:- Is the addition of fish-oils to HMG-CoA reductase inhibitors more advantageous in improving long term survival in diabetics with LDL-cholesterols > 130 mg/dl than HMG-CoA reductase inhibitors agent alone? (randomized, very long-term, active-controlled, double-blind)

Study #99-02:- Is the combination of fish-oils and HMG-CoA reductase inhibitors more advantageous in improving long term survival in diabetics with LDL-cholesterols < or = 130 mg/dl than either agent alone or than placebo? (randomized, very long-term, placebo-controlled double-dummy, double-blind, 2x2 factorial)

Study #99-03:- Do "selective" K-channel antagonists offer improved long term survival in diabetes compared to "non-selective" agents? (randomized, very long-term, active-controlled, double-blind, 4 arm, double-dummy)

Study #99-04:-Does the combination of insulin plus metformin improve long term survival in obese diabetics [who have failed metformin monotherapy] better than (1) insulin alone or (2) combination metformin plus "selective" K-channel antagonists or (3) combination metformin plus thiazolidinediones? (randomized, active-controlled, very long-term, insulin-open otherwise double-blind, double-dummy, 4 arm)

Study #99-05:-Does the combination of "selective" K-channel antagonists plus insulin improve long term survival in non-obese diabetics [who have failed sulfonylurea monotherapy] better than (1) insulin alone or (2) combination "selective" K-channel antagonists plus metformin or (3) combination "selective" K-channel antagonists plus thiazolidinediones? (randomized, active-controlled, very long-term, insulin-open otherwise double-blind, double-dummy, 4 arm)

Study #99-06:-Does the combination of a thiazolidinedione plus insulin improve long-term survival in non-obese diabetics [who have failed thiazolidinedione monotherapy] better than (1) insulin alone or (2) combination of a thiazolidinedione plus metformin or (3) combination of a thiazolidinedione plus "selective" K-channel antagonists? (randomized, active-controlled, very long-term, insulin-open otherwise double-blind, double-dummy, 4 arm)

Study #99-07:-Does the combination of insulin plus metformin improve long term survival in non-obese diabetics [who have failed metformin monotherapy] better than (1) insulin alone or (2) combination metformin plus "selective" K-channel antagonists or (3) combination metformin plus thiazolidinediones? (randomized, active-controlled, very long-term, insulin-open otherwise double-blind, double-dummy, 4 arm)

Study #99-08:-Is there a long-term mortality difference when non-obese diabetics who have failed dietary therapy (HbA1c > 8%) are:

A) initially prescribed (1) a thiazolidinedione versus (2) insulin versus (3) metformin versus (4) a "selective" K-channel antagonist and

B) insulin is subsequently added when primary failure occurs? (randomized, active-controlled, very long-term, insulin-open otherwise double-blind, double-dummy, 4 arm)

(Interested? Patient or prospective investigator? Please respond here)

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