American Diabetes Association

Table 1—

Comparison of model and trial results: trials that include people with diabetes

Name of trial	Population	Outcome	Years	Initial size	Treatment group	Result (%)
Name of trial	Population	Outcome	Years	Initial size	Treatment group				Model	Trial
UKPDS	Newly diagnosed type 2 diabetes	Myocardial infarction	12	1,138	Conventional	19.6	19
	Newly diagnosed type 2 diabetes				2,729	Intensive^*	15.4	16
		Albuminuria	12	1,138	Conventional	33.8	34
				2,729	Intensive	21.3	23
		Proteinuria	12	1,138	Conventional	9.8	10.3
				2,729	Intensive	7.6	6.8
		Retinopathy	12	1,138	Conventional	50	49
				2,729	Intensive	39	39
DPP^†	Impaired glucose tolerance, Impaired fasting glucose and Overweight	Progression to diabetes	4	1,082	Control	38	37
					1,073	Metformin	31	28
					1,079	Lifestyle	21	20
HPS^†	High risk for CAD events^‡	Major coronary events	5	10,267	Placebo	11.7	11.8
				10,269	Simvastatin	8	8.8
		CHD death	5	10,267	Placebo	6.2	6.9
				10,269	Simvastatin	5	5.5
HOPE	High CAD risk^§	Myocardial infarction	4.5	4,652	Placebo	11.3	11.3
				4,645	Ramipril	8.9	9
MICRO-HOPE^†	High CAD risk, type 2 diabetes	Myocardial infarction	4	1,808	Placebo	13	12.9
	High CAD risk, type 2 diabetes				1,769	Ramipril	9	10.2
CARE^‖	Recent myocardial infarction, average cholesterol	Myocardial infarction	5	2,078	Placebo	12.3	13.2
					2,081	Simvastatin	9.3	10.2
			CHD death	5	2,078	Placebo	6.2	5.7
				2,081	Simvastatin	4.4	4.6
Lewis	Type 1 diabetes, nephropathy	Doubling of creatinine	4	202	Placebo	37	33
	Type 1 diabetes, nephropathy				207	Captopril	19	22
IRMA-2	Type 2 diabetes, micro-albuminurea	Nephropathy	1.8	201	Placebo	17.4	15
	Type 2 diabetes, micro-albuminurea				195	Irbesartan 150	9.5	9
				194	Irbesartan 300	5.3	4.5
DCCT primary	Type 1 diabetes without retinopathy	Retinopathy	8	378	Loose control	34	38
	Type 1 diabetes without retinopathy				348	Tight control	9.3	10
		Albuminuria	8	378	Loose control	29	28
				348	Tight control	17	15
		Proteinuria	9	378	Loose control	32	25
				348	Tight control	15	18
DCCT secondary	Type 1 diabetes with retinopathy	Retinopathy	8	352	Loose control	52	48
	Type 1 diabetes with retinopathy				363	Tight control	22	21
		Albuminuria	8	352	Loose control	33	35
				363	Tight control	22	22
		Proteinuria	9	352	Loose control	9	11
				363	Tight control	5	6
IDNT	Type 2 diabetes, nephropathy	Doubling of creatinine	4	579	Placebo	35	37
	Type 2 diabetes, nephropathy				569	Irbesartan	26	28

Name of trial	Population	Outcome	Years	Initial size	Treatment group	Result (%)
Name of trial	Population	Outcome	Years	Initial size	Treatment group				Model	Trial
UKPDS	Newly diagnosed type 2 diabetes	Myocardial infarction	12	1,138	Conventional	19.6	19
	Newly diagnosed type 2 diabetes				2,729	Intensive^*	15.4	16
		Albuminuria	12	1,138	Conventional	33.8	34
				2,729	Intensive	21.3	23
		Proteinuria	12	1,138	Conventional	9.8	10.3
				2,729	Intensive	7.6	6.8
		Retinopathy	12	1,138	Conventional	50	49
				2,729	Intensive	39	39
DPP^†	Impaired glucose tolerance, Impaired fasting glucose and Overweight	Progression to diabetes	4	1,082	Control	38	37
					1,073	Metformin	31	28
					1,079	Lifestyle	21	20
HPS^†	High risk for CAD events^‡	Major coronary events	5	10,267	Placebo	11.7	11.8
				10,269	Simvastatin	8	8.8
		CHD death	5	10,267	Placebo	6.2	6.9
				10,269	Simvastatin	5	5.5
HOPE	High CAD risk^§	Myocardial infarction	4.5	4,652	Placebo	11.3	11.3
				4,645	Ramipril	8.9	9
MICRO-HOPE^†	High CAD risk, type 2 diabetes	Myocardial infarction	4	1,808	Placebo	13	12.9
	High CAD risk, type 2 diabetes				1,769	Ramipril	9	10.2
CARE^‖	Recent myocardial infarction, average cholesterol	Myocardial infarction	5	2,078	Placebo	12.3	13.2
					2,081	Simvastatin	9.3	10.2
			CHD death	5	2,078	Placebo	6.2	5.7
				2,081	Simvastatin	4.4	4.6
Lewis	Type 1 diabetes, nephropathy	Doubling of creatinine	4	202	Placebo	37	33
	Type 1 diabetes, nephropathy				207	Captopril	19	22
IRMA-2	Type 2 diabetes, micro-albuminurea	Nephropathy	1.8	201	Placebo	17.4	15
	Type 2 diabetes, micro-albuminurea				195	Irbesartan 150	9.5	9
				194	Irbesartan 300	5.3	4.5
DCCT primary	Type 1 diabetes without retinopathy	Retinopathy	8	378	Loose control	34	38
	Type 1 diabetes without retinopathy				348	Tight control	9.3	10
		Albuminuria	8	378	Loose control	29	28
				348	Tight control	17	15
		Proteinuria	9	378	Loose control	32	25
				348	Tight control	15	18
DCCT secondary	Type 1 diabetes with retinopathy	Retinopathy	8	352	Loose control	52	48
	Type 1 diabetes with retinopathy				363	Tight control	22	21
		Albuminuria	8	352	Loose control	33	35
				363	Tight control	22	22
		Proteinuria	9	352	Loose control	9	11
				363	Tight control	5	6
IDNT	Type 2 diabetes, nephropathy	Doubling of creatinine	4	579	Placebo	35	37
	Type 2 diabetes, nephropathy				569	Irbesartan	26	28

Sulphonylurea, Metformin, or insulin;

†

not used to build physiology model;

‡

CAD, occlusive arterial disease or diabetes;

CAD or diabetes plus at least one CVD risk factor;

‖

eight additional validation exercises were done for the under-60 and over-60 age-groups. No model results were significantly different from trial results.

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