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148

CHAPTER 10 Therapy for Type 2 Diabetes

engage in aerobic exercise for this reason—not only can patients lose weight,

but peripheral insulin resistance is somewhat overcome. Some studies have

shown a 50 to 100 percent increase in insulin sensitivity and a 10 to 20 percent

reduction in HbA1c with regular aerobic exercise.

Some T2DM patients are able to manage their condition with lifestyle

changes only, but many require the addition of one or multiple medications

to achieve an HbA1c of 7 percent or less, as recommended by the American

Diabetes Association.

Medical therapy

Biguanides

With its relatively low cost, few side effects, cardioprotective effects, and mod-

erate reduction of HbA1c by 1 to 2 percent, metformin is an ideal ﬁ rst-line

pharmacological therapy for patients with diabetes. It has the additional effect

of positively affecting cholesterol levels with a reduction in LDL and triglyc-

erides and improvement in HDL levels compared to placebo.

7,8

Additional

cardioprotective features include anticoagulant properties with a reduction in

ﬁ brinogen and anti-inﬂ ammatory factors, including C-reactive protein levels.

Reduced mortality was noted with the use of this agent in the United Kingdom

Prospective Diabetes Study (UKPDS). Lower mortality was also noted in an

observational analysis from the REACH registry.

The full mechanism of action

of metformin has not been elicited, but it is thought to suppress hepatic glucose

production, likely by inhibiting gluconeogenesis, and does not increase insulin

secretion. It is also believed that metformin increases muscle utilization of glu-

cose by increasing insulin sensitivity in the muscles or decreasing peripheral

resistance.

The most common side effect of metformin is gastrointestinal (GI) upset.

Thus, metformin is titrated from 500 mg once a day up to a usual dose of

1,000 mg two times a day or until intolerable GI symptoms occur. Rarely, lactic

acidosis may occur, leading to a 20 percent mortality rate. However, all cases

have occurred in patients in whom the drug was relatively contraindicated, such

as those with renal insufﬁ ciency (creatinine above 1.5 mg/dL in men and above

1.4 mg/dL in women). Caution for its use applies to patients with hepatic dys-

function, heart failure, a history of alcoholism, and metabolic acidosis.

Sulfonylureas and glinides

If metformin is not sufﬁ cient to maintain an HbA1c of 7.0 percent or less, then

adding a sulfonylurea (e.g., glimepiride, glipizide, or glyburide) or glinide (e.g.,

repaglinide) may be required. Both classes lower HbA1c by 1 to 2 percent.

Sulfonylureas bind to ATP-dependent K

channels on pancreatic beta cells,

causing their depolarization and release of insulin. Glinides work similarly but

bind to a different part of the same K

channel. The difference lies in the dura-

tion of action: beta cells respond more rapidly to glinides and for a shorter

period of time, leading a quick rise and fall in insulin levels. Therefore, glinides

have a lower risk of hypoglycemia compared to sulfonylureas. Regardless, all

patients taking sulfonylureas or glinides must be taught the signs, symptoms,

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149

CHAPTER 10 Therapy for Type 2 Diabetes

and treatment of hypoglycemia. A major disadvantage of these two classes of

drugs is weight gain of 1 to 3 pounds per year.

Thiazolidinediones

Thiazolidinediones bind to a nuclear receptor, peroxisome proliferator-activated

receptor γ (PPAR- γ ), activating genes that increase glucose utilization, thereby

enhancing insulin sensitivity in muscle and fat tissue. HbA1c is lowered by 0.5 to

2.5 percent with this class of drugs, but with major disadvantages. Thiazolidinediones

in clinical trials (DREAM, ACTNOW, and TIPOD/PIPOD) have been shown to be

protective of beta-cell function, thus reducing the incidence and progression of

diabetes.

10–13

Encouraging data on the use of pioglitazone on cardiovascular and

stroke beneﬁ ts were noted in clinical trials.

Patients may experience signiﬁ cant

weight gain of 1 to 13 pounds per year, edema, bone fractures, and anemia. On

rare occasions, use may exacerbate congestive heart failure.

Controversy in thiazolidinedione use centers on the increase in cardiac

events, especially with rosiglitazone. In one meta-analysis, the odds ratio for

myocardial infarctions was 1.43 (95 percent CI 1.03–1.98, p = 0.03) in the

rosiglitazone group compared to control.

A second study in elderly Medicare

beneﬁ ciaries prescribed rosiglitazone found an increased risk of stroke, heart

failure, and all-cause mortality compared to patients prescribed pioglitazone.

As a result, rosiglitazone has largely been taken off the market in European

countries and its use is restricted in the United States.

Alpha-glucosidase inhibitors

This class of drugs, which includes acarbose and miglitol, acts by inhibiting the

critical enzyme involved in intestinal carbohydrate digestion. Carbohydrate

absorption is impaired. Unsurprisingly, the most common side effects are GI

ones–in particular, ﬂ atulence and diarrhea. However, major advantages are

that it acts within the gut, making it a nonsystemic medication, and it lowers

postprandial glucose. Patients may experience a change of 0.5 to 1 percent in

HbA1c and moderate weight loss of up to 10 pounds.

Incretin analogs

Incretin analogs include GLP-1 receptor agonists and dipeptidyl peptidase-4

(DPP-4) inhibitors. GLP-1 is an intestinal hormone responsible for the incretin

effect; it stimulates insulin release in the presence of glucose consumed orally,

promotes peripheral insulin sensitivity, decreases glucagon secretion, and slows

gastric emptying. GLP-1 has a short half-life due to rapid degradation by DPP-4.

Pharmacologically, GLP-1 receptor agonists act as incretin agonists while DPP-4

inhibitors act as incretin enhancers.

GLP-1 receptor agonists include exenatide and liraglutide. GLP-1 agonists are

injectable. One major beneﬁ t is weight loss; in one systematic review, patients

with diabetes lost 6.2 pounds on average while patients without diabetes lost

approximately 7 pounds. Other beneﬁ ts included enhanced blood pressure,

cholesterol, and glycemic control.

Reductions in HbA1c are between 1 and

2 percent. DPP-4 inhibitors, such as sitagliptin and saxagliptin, have the advan-

tage of being available orally; this class of antidiabetic agents does not confer

signiﬁ cant weight loss.

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150

CHAPTER 10 Therapy for Type 2 Diabetes

Overall, glucose-dependent mechanisms of incretin therapy display lower

rates of hypoglycemia compared to insulin or sulfonylureas. However, cases of

pancreatitis have been observed and as a newer class of drugs, long-term safety

is not known, though large outcome trials are ongoing.

Pramlintide

Pramlintide is a recently introduced amylin analog that can also be used in

patients with T1DM. Amylin is a naturally produced peptide hormone co-

secreted with insulin by pancreatic beta cells. Studies in rodents have shown

that amylin induces delayed gastric emptying and reduces food intake;

a com-

mon side effect of pramlintide is anorexia.

An added beneﬁ t is the inhibition of

arginine-induced postprandial glucagon secretion. Some reports have suggested

that postprandial glucose (PPG) more signiﬁ cantly contributes to HbA1c values

than does fasting glucose, especially at lower values.

This implies that PPG

may be a better marker of cardiovascular outcomes and all-cause mortality.

one systematic review, the authors identiﬁ ed an HbA1c reduction of 0.33 per-

cent and a weight loss of 2.5 kg in eight randomized clinical trials of between

1 and 52 weeks with use of pramlintide.

Pramlintide may precipitate hypoglycemia, especially when used concur-

rently with insulin, although frequent self-monitoring of blood glucose and dose

titration may reduce the risk.

Its high cost and injectable mode of administra-

tion can be prohibitive to many patients, who may also be on injectable forms

of insulin as well.

Dopamine-2 agonists

Bromocriptine is a dopamine-2 agonist recently recognized as a treatment for

T2DM. Its speciﬁ c mechanism of action remains unclear, as it acts on the central

nervous system and the brain is not readily accessible for biopsy studies. What

is known, however, is that it reduces PPG by suppressing hepatic gluconeogen-

esis and when combined with other antidiabetic agents can produce a 0.5 to

1 percent reduction in HbA1c. Major adverse cardiovascular events (myocar-

dial infarction, stroke, and death) appear to be reduced in patients treated with

bromocriptine versus placebo over a 52-week period.

Insulin

A variety of insulin preparations are available based on the onset and duration

of action. Although insulin was originally extracted and puriﬁ ed from animals,

human insulin is now isolated using recombinant DNA technology, lessening

the risk of allergies or lipodystrophy at the site of injection. Short-acting insu-

lins include lispro, aspart, glulisine, and regular insulin, while long-acting insulins

encompass glargine, determir, and Neutral Protamine Hagedorn (NPH) insulins.

Other preparations may include a combination of short-acting and long-acting

insulins dispensed together. The differences are mainly structural; substitution

of a single amino acid within the dual-chained insulin molecule alters the rate

of formation and degradation of hexamers at the site of injection. In high-risk

patients with dysglycemia, early use of insulin glargine targeted to normalize

fasting glucose did not reduce cardiovascular events over a median of 6.2 years

versus standard treatment.

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151

CHAPTER 10 Therapy for Type 2 Diabetes

The major disadvantages to this drug class include weight gain and an

increased risk of hypoglycemia. Patients must be educated on the signs and

symptoms of hypoglycemia as well as immediate treatment, particularly when

beginning insulin. The non-oral mode of administration may also be a disadvan-

tage, as peptide hormones taken orally will be broken down prior to absorp-

tion. Certain preparations must be kept cold. However, the main advantage is

that there is no upper limit to the dose and titration can be easily performed.

Moreover, insulin can produce the greatest decrease in HbA1c; a reduction of

1.5 to 3.5 percent is not uncommon.

Emerging pharmacotherapies

Dapagliﬂ ozin is a novel drug still under investigation in the United States but

has recently been approved for use in the European Union. Its mechanism is

unique; as a selective and reversible inhibitor of the sodium-glucose co-trans-

porter 2 (SGLT2), it decreases renal reabsorption of glucose and increases

renal excretion of glucose. Clinical trials of safety are ongoing, but studies have

consistently demonstrated improved glycemic control, a reduction in HbA1c,

and weight loss. However, there have been reports of a slightly increased inci-

dence of bladder and breast cancers.

26–28

A large cardiovascular outcome trial

is planned.

Considerations for pharmacological therapy

Major adverse effects such as stroke and cardiac-related events may be a deter-

rent to using some of the antidiabetic medications. However, it is of interest to

note that the beneﬁ ts of beginning and continuing medical therapy far outweigh

the risks of major adverse effects, as Figure 10.1 demonstrates.

It is also critical to note that T2DM is a progressive, chronic disease in which

aggressive pharmacological therapy may not control blood sugars indeﬁ nitely.

The United Kingdom Prospective Diabetes Study (UKPDS) demonstrated that

beta-cell function continues to deteriorate over time despite diet, exercise,

and hypoglycemic agents.

In one trial for well-controlled patients who were

prescribed a single oral hypoglycemic agent, the mean time of deterioration

of glycemic control was 45 months on metformin, 33 months on glyburide,

and 60 months on rosiglitazone.

For patients on metformin who were pre-

scribed a sulfonylurea, median HbA1c levels resumed deteriorating as early as

6 months at a rate similar to that observed for metformin alone.

With con-

tinuing decline in the function of beta cells, single or even multiple agents are no

longer sufﬁ cient to control blood glucose levels and patients may require insu-

lin therapy. However, psychological barriers exist to initiating insulin therapy,

including concern over hypoglycemia, permanent need for insulin, perceived

failure, and fear of needles.

For those who do initiate insulin therapy, less than

half achieve an HbA1c of 7 percent or less.

Surgical approaches

For some patients in whom a combination of lifestyle adjustments and multiple

hypoglycemic agents cannot control diabetes, bariatric surgery represents an

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152

CHAPTER 10 Therapy for Type 2 Diabetes

–

20 0 20

Death

Microvascular disease

Exenatide pancreatitis

Metformin lactic acidosis

Rosiglitazone MI

Thiazolidinedione CHF

Thiazolidinedione bone fracture

Blindness

End stage renal disease

Pancreatitis

Stroke (no prior MI)

MI (no prior MI)

Stroke (prior MI)

Complications of diabetes

Adverse events associated with therapy

Risk reduction with intensive diabetes control (type 2)

MI (prior MI)

CHF

Death

PVD

Severe hypoglycemia with intensive therapy

Diabetes-related death

Intensive (insulin/sulfonylurea) vs. conventional

therapy in newly diagnosed type 2 diabetes

Intensive (metformin) vs. conventional therapy

in overweight patients with newly diagnosed

type 2 diabetes

Events per 1000 patient-years

60 80 100

Figure 10.1 Major macrovascular and microvascular complications of diabetes are

reduced with intensive glycemic control with medications. Despite the risk of serious

complications such as severe hypoglycemia or myocardial infarction, medications demon-

strate a favorable risk-to-beneﬁ t ratio. (Reprinted from The American Journal of Medicine ,

Vol. 123/ed. 4, Bergenstal RM, Bailey CJ, and Kendall DM. Type 2 Diabetes: Assessing the

Relative Risks and Beneﬁ ts of Glucose-lowering Medications, 374.e9–374.e18, 2010, with

permission from Elsevier.)

effective treatment. Observational studies have shown that along with massive

weight loss, bariatric surgery improves glycemic control, cardiovascular risk fac-

tors, quality of life, and mortality from cancer and cardiovascular disease.

34,35

Bariatric surgery affects weight loss through malabsorptive and/or restrictive

mechanisms. Biliopancreatic diversion is a malabsorptive procedure that short-

ens the length and absorptive surface of the small intestine, thereby decreasing

nutritional absorption. Adjustable gastric banding and sleeve gastrectomy are

among the most popular restrictive procedures; they work by limiting caloric

intake via restriction of stomach size while leaving the absorptive capacity of

the small intestine intact. Gastric bypass and gastric bypass with sleeve gastrec-

tomy are classiﬁ ed as both malabsorptive and restrictive. In gastric bypass, a

majority of the stomach is circumvented, leaving a walnut-sized gastric pouch,

and the small intestine is reconﬁ gured to decrease absorption. With sleeve

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153

CHAPTER 10 Therapy for Type 2 Diabetes

gastrectomy, 80 percent of the stomach is removed, leaving a “sleeve” of the

stomach, increasing satiety sooner and decreasing food intake.

Bariatric surgery can induce remission from diabetes within days of sur-

gery, before signiﬁ cant weight loss has occurred.

The mechanism by which

this occurs is still an area of active research. Three major hypotheses have

been proposed as explanations.

With decreased caloric intake, weight loss

increases insulin sensitivity and allows beta cells to rest and not produce as

much insulin. A second hypothesis centers on reduced lipotoxicity and inﬂ am-

mation related to weight loss; a study showed that 1 year after Roux-en-Y gas-

tric bypass, obese patients displayed an insulin sensitivity proﬁ le similar to that

of non-obese and non-overweight subjects.

The ﬁ nal hypothesis capitalizes on

gut hormones secreted in response to food. Within this, the foregut hypothesis

suggests that nutrient interactions with the duodenum are diabetogenic and

bypass of this segment counteracts this effect, while the hindgut hypothesis

proposes that accelerated transport of nutrients increases production of insuli-

notropic substances (primarily GLP-1).

In a large meta-analysis, resolution of diabetes, deﬁ ned as the ability to

maintain euglycemia without the aid of antidiabetic medications, was found in

76.8 percent of all bariatric surgery patients. Patients who underwent malab-

sorptive procedures such as biliopancreatic diversion or duodenal switch had

higher rates of resolution, at 97.9 percent, than patients who underwent restric-

tive procedures such as gastric banding, at 47.8 percent. However, regardless

of the surgical procedure, greater than 80 percent of patients experienced

improvement, if not remission, of their diabetes.

Improvement in diabetes may

be tethered to beta-cell function and length of diabetes. Remission is linked to a

shorter duration of diabetes and good preoperative control of diabetes.

These procedures may cost more than $30,000 and may not be fully covered

by insurance, making it a signiﬁ cant ﬁ nancial investment. However, for those

with very high obesity-related health costs, such as T2DM, bariatric surgery

represents a cost-saving measure in the long term and likely confers additional

years of life to morbidly obese patients.

Moreover, many bariatric surgery

patients experience an improved quality of life via enhanced socioeconomic

opportunities and increased productivity.

In one randomized controlled trial with 150 patients, the STAMPEDE trial,

intensive medical therapy with bariatric surgery (Roux-en-Y gastric bypass or

sleeve gastrectomy) improved glycemic control compared to intensive medical

therapy alone over 12 months.

Intensive medical therapy aimed to achieve

optimal glycemic control through lifestyle changes, self-monitoring of blood

glucose, and use of oral and/or injectable hypoglycemic agents approved by the

U.S. Food and Drug Administration (FDA). Twelve percent of patients in the

medical therapy group, 42 percent in the gastric bypass group ( p = 0.002), and

37 percent in the sleeve gastrectomy group ( p = 0.008) achieved the primary

end point of an HbA1c of 6.0 percent or less 12 months after treatment. The

number of medications needed to control blood glucose levels decreased signif-

icantly in patients who underwent a bariatric surgical procedure but increased

in patients receiving intensive medical therapy only. Weight loss was greater in

individuals who underwent bariatric surgery compared to those treated with

medical therapy alone, as noted in Figure 10.2.

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154

CHAPTER 10 Therapy for Type 2 Diabetes

A smaller randomized controlled trial conducted in Italy with 60 patients

saw similar results: 75 percent of patients who underwent gastric bypass and

95 percent of biliopancreatic diversion patients attained glycemic control.

Bariatric surgery has also been shown in one study to delay the onset of

diabetes.

The Swedish Obese Subjects study is a prospective, nonrandom-

ized study comparing the long-term effects of bariatric surgery with standard

treatment for obesity in Sweden. Control individuals were matched to individu-

als having undergone bariatric surgery. At the 15-year follow-up examination,

diabetes developed at an incident rate of 28.4 cases per 1,000 person-years in

the control group and 6.8 cases per 1,000 person-years in the bariatric surgery

group.

Beyond its remarkable beneﬁ ts in improving glycemic control, bariatric surgery

has also been shown to improve other comorbidities and quality of life in mor-

bidly obese individuals. Obstructive sleep apnea improves or resolves in 83.6 per-

cent of patients, hypertension in 78.5 percent of patients, and hyperlipidemia in

greater than 70 percent of patients.

As a result, medications for these conditions

are stopped in a majority of patients. Unsurprisingly, with substantial weight loss,

patients appear to have decreased mortality. In a retrospective cohort study that

Change in Glycated HemoglobinA

B Change in Fasting Plasma Glucose

Average No. of Diabetes Medications Change in BMI

0.0

Intensive medical therapy Roux-en-Y gastric bypass Sleeve gastrectomy

–20

–40

–60

–80

–100

–120

–140

–160

Change in Glycated Hemoglobin

(percentage points)

Change in Fasting Plasma

Glucose (mg/dl)

Average No. of Diabetes

Medications

Change in BMI

–0.5

–1.0

–1.5

–2.0

–2.5

–3.0

–3.5

Baseline

Value at Visit

Intensive medical therapy

Roux-en-Y gastric bypass

Sleeve gastrectomy

8.9

9.3

9.5

7.7

6.8

7.1

6.3

6.7

7.4

6.4

6.7

7.5

6.4

6.6

Value at Visit

Intensive medical therapy

Roux-en-Y gastric bypass

Sleeve gastrectomy

155

193

164

122

109

118

113

104

120

102

120

Value at Visit

Intensive medical therapy

Roux-en-Y gastric bypass

Sleeve gastrectomy

2.8

3.5

–2

–4

–6

–8

–10

–12

3.0

2.5

2.0

1.5

1.0

0.5

0.0

2.6

2.4

3.1

1.1

3.1

0.6

0.9

3.0

0.4

0.8

3.0

0.3

0.9

Value at Visit

Intensive medical therapy

Roux-en-Y gastric bypass

Sleeve gastrectomy

36.3

37.0

36.1

35.4

31.8

31.3

34.8

28.2

28.3

34.5

26.9

27.3

34.4

26.8

27.2

Month

369

p < 0.001

p=0.02

p=0.001

p < 0.001

Baseline

Month

36912

Baseline

Month

36912

Baseline

Month

36912

Figure 10.2 Over 12 months, both Roux-en-Y gastric bypass and sleeve gastrectomy

procedures for bariatric surgery were superior to intensive medical therapy in markers

of diabetes control, including HbA1c (A), fasting plasma glucose (B), average number of

diabetes medications (C), and change in BMI (D). (From New England Journal of Medicine ,

Vol. 366/no. 17, Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier

CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric Surgery versus Intensive Medical

Therapy in Obese Patients with Diabetes, 1567–1576, 2012. Reprinted with permission

from Massachusetts Medical Society.)

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155

CHAPTER 10 Therapy for Type 2 Diabetes

matched 7,925 Roux-en-Y gastric bypass patients with 7,925 severely obese con-

trols, surgery was associated with a 40 percent reduction in adjusted long-term

mortality from any cause over a mean follow-up of 7.1 years.

Notably, research-

ers also found a 56 percent reduction of death from coronary artery disease and

a 60 percent reduction of death from cancer in surgical patients.

Surgery is not without its complications. While the mortality rates are

low, at 0.1 percent,

patients should be counseled regarding the risks of

undergoing major abdominal surgery, including adverse effects to anesthesia,

infection, bleeding, abdominal hernias, and bowel blockage from scar tissue.

Postoperatively, patients commonly experience dumping syndrome, a constel-

lation of symptoms that includes abdominal cramps, lightheadedness, nausea,

and diarrhea due to increased motility of undigested nutrients through the small

bowel. Patients must also be aware of vitamin and mineral deﬁ ciencies, espe-

cially those of vitamin D, thiamine, vitamin B12, calcium, and iron. Gallstones

form more readily as a result of rapid weight loss.

Increasingly, laparoscopic surgeries have been performed, and studies have

shown improved or comparable outcomes over open surgeries. One meta-

analysis demonstrated a lower risk of wound infection and incisional hernia but

a similar risk of reoperation, anastomotic leak, and all-cause mortality in surger-

ies performed laparoscopically compared to open surgeries.

The American Society for Metabolic and Bariatric Surgery (ASMBS) estimated

that 220,000 people received bariatric surgery in 2008, a dramatic increase

compared to 16,000 patients in the 1990s. The current National Institutes of

Health (NIH) guidelines state that bariatric surgery can be considered in indi-

viduals with a BMI of at least 40 kg/m

or at least 35 kg/m

with comorbidities,

such as diabetes. The pool of eligible candidates has also been increased by

recent FDA approval to lower the threshold to a BMI of at least 30 kg/m

for

those undergoing the lap-band surgery, although this has been controversial. As

the population of obese individuals increases, there may be an increasing need

for bariatric surgeons, dieticians, and endocrinologists. Although questions of

which patients should qualify for bariatric surgery may persist, one thing is clear:

weight loss confers innumerable beneﬁ ts to the individual, including improve-

ment or resolution of diabetes, reduction in risk factors for coronary artery

disease, and improvements in measures of quality of life.

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