Insulin Analogs or Premixed Insulin Analogs in Combination With Oral Agents for Treatment of Type 2 Diabetes

Philip Levy, MD, FACE

April 16, 2007

Glycemic Targets

Currently accepted treatment targets for A1C levels, according to the American Diabetes Association (ADA), are less than 7.0% or as close to normal as possible without causing undue hypoglycemia.^[12] The American Association of Clinical Endocrinologists (AACE) recommends a target of 6.5% or less.^[13] However, in a study reporting glycemic control rates among US adults with type 2 diabetes from 1999 to 2000,^[14] less than 36% of patients reached a goal of less than 7%.

The ADA and AACE recommendations also differ slightly for optimal control fasting plasma glucose (FPG) and postprandial glucose (PPG) ( Table 1 ). Although both are strongly correlated with A1C,^[15] PPG may more accurately predict overall glycemic control and correlate better with A1C than FPG.^[16] The relative contribution of PPG to A1C increases as glycemic control improves while the relative contribution of FPG increases gradually with rising A1C.^[17]

References

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Glycemic Goals
Parameter	Normal	ADA Goals	ACE/AACE Goals
Fasting plasma glucose (mg/dL)	< 100	90-130	< 110
Postprandial plasma glucose (mg/dL)	< 120	< 180*	< 140**
A1C (%)	4-6	< 7***	≤ 6.5

*1-2 hours post-meal
**2 hours post-meal
***as close to normal as possible without undue risk of hypoglycemia

Noninsulin Pharmacotherapies for Management of Type 2 Diabetes
Insulin Secretagogues	Insulin Sensitizers	Other Agents
Sulfonylureas Chlorpropamide Glyburide Glimepiride Glipizide Gliclazide Tolbutamide Glinides Nateglinide Repaglinide	Metformin Thiazolidinediones Rosiglitazone Pioglitazone	alpha-Glucosidase Inhibitors Acarbose Miglitol GLP-1 Analogs* Exenatide DPP-IV Inhibitors* Sitagliptin Amylin Analog Pramlintide

Combination products are also available, most of which combine a secretagogue with a sensitizer; *several other agents in this class are in clinical development

Noninsulin Pharmacotherapies for Management of Type 2 Diabetes
Insulin Secretagogues	Insulin Sensitizers	Other Agents
Sulfonylureas Chlorpropamide Glyburide Glimepiride Glipizide Gliclazide Tolbutamide Glinides Nateglinide Repaglinide	Metformin Thiazolidinediones Rosiglitazone Pioglitazone	alpha-Glucosidase Inhibitors Acarbose Miglitol GLP-1 Analogs* Exenatide DPP-IV Inhibitors* Sitagliptin Amylin Analog Pramlintide

Combination products are also available, most of which combine a secretagogue with a sensitizer; *several other agents in this class are in clinical development

Comparison of Insulin Preparations by Pharmacodynamics and Cost
Insulin Preparation	PD Parameters			Cost*
Insulin Preparation	Onset (h)	T_{peak activity} (h)	Duration (h)	Per 10-mL Vial**
Rapid-acting analogs
Insulin aspart	0.17-0.33	1-3	3-5	$81
Insulin glulisine	0.25	0.5-1.5	5.3	$78
Insulin lispro	0.25-0.5	0.5-2.5	3-6.5	$78
Short-acting human
Regular human Insulin (RHI)	0.5-1	1-5	6-10	$35
Intermediate-acting human
Neutral protamine Hagedorn (NPH)	1-2	6-14	16-24	$35
Long-acting analogs
Insulin detemir	0.8-2	6-8	Up to 24	$84
Insulin glargine	1.1	2-20	Up to 24	$76
Premixes (human)
NPH/RHI 70/30 or 50/50	0.5	1.5-12	Up to 24	$32-36
Premixes (analogs)
Biphasic insulin aspart 70/30	0.17-0.33	1-4	Up to 24	$84 ($153 for five 3-mL pens)
Insulin lispro 75/25	0.25-0.5	≤ 2	Approx. 22	$84 ($148 for five 3-mL pens)
Insulin lispro 50/50	0.25-0.5	0.5-1.5	Approx. 22	$156 (five 3-mL pens)
Inhaled insulin	0.17-0.33	0.5-1.5	Approx. 6	$134 for kit that contains 90 × 1 mg plus 90 × 3 mg blister packs***

*Except for pen devices, does not include the cost of the needles and syringes, or, in the case of inhaled insulin, the inhaler, chamber, or release unit that must be replaced every 2 weeks; **unless otherwise noted; ***approximately equivalent to 990 units of RHI (ie, one 10-mL vial of 100 unit/mL); pharmacodynamic data from respective prescribing information. Cost data from Red Book 2006^[83] and www.drugstore.com, accessed December 14, 2006. Prices are for comparison and could vary considerably, depending on source.

Starting and Titration Schedule for a Basal Insulin Analog
Self-Monitored FPG (mg/dL)	Dosage Increase (units/day)
≥ 180	8
≥ 140 to < 180	6
≥ 120 to < 140	4
> 100 to < 120	2

FPG = fasting plasma glucose; *no increase if FPG is < 72 mg/dL in the preceding week; decrease dosage (2-4 units/day) if FPG is < 56 mg/dL or severe hypoglycemia (requiring assistance) occurred within the preceding week; copyright 2003 American Diabetes Association. From Diabetes Care 2003;26:3080-3086; reprinted with permission from The American Diabetes Association.

Starting and Titration Schedule for a Premixed Insulin Analog
Blood Glucose Values	Starting Dose	Dose Titration*
Baseline FPG < 180 mg/dL FPG ≥ 180 mg/dL	5 units before breakfast and supper 6 units before breakfast and supper
After Initial Therapy FPG < 80 mg/dL FPG 80-110 mg/dL FPG 111-140 mg/dL FPG 141-180 mg/dL FPG > 180 mg/dL		Reduce by 2 units No change Increase by 2 units Increase by 4 units Increase by 6 units

FPG = fasting plasma glucose; *increase in total daily dose should not exceed the greater of 10 units or 10% of the total daily dose; morning dose is based on pre-supper blood glucose reading; supper dose is based on pre-breakfast blood glucose reading; the dose titration is based on blood glucose values from the preceding 3 days; reprinted from Rolla AR, Rakel RE. Practical approaches to insulin therapy for type 2 diabetes mellitus with premixed insulin analogues. Clin Ther. 2005;27:1113-1125, with permission from Excerpta Medica, Inc.

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Insulin Analogs or Premixed Insulin Analogs in Combination With Oral Agents for Treatment of Type 2 Diabetes

Glycemic Targets

Tables

Tables

Tables

Tables

Tables

Tables

References

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