Symlin

Name: Symlin

Manufacturer

  • Amylin Pharmaceuticals, LLC

Symlin and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Symlin falls into category C. There are no well-controlled studies in pregnant women. It is not known if Symlin will harm your unborn baby. Symlin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Symlin Usage

Administer Symlin exactly as prescribed.

Symlin comes in an injectable form to be given just under the skin and is typically injected just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

Do not inject Symlin until you have been instructed and trained properly by your healthcare provider.

Always follow your healthcare provider's instructions on administration of Symlin exactly. You may refer to the following section for additional information on proper use of Symlin.

  • Your healthcare provider will tell you how much Symlin to use and when to use it.
  • Your healthcare provider may change your dose if needed.
  • If you stop taking Symlin for any reason, such as surgery or illness, talk to your healthcare provider about how to restart Symlin.
  • To reduce the risk of hypoglycemia, it is important that you plan your meals and physical activity every day while you use Symlin. Plan for what you will eat and when you will eat your meals. 
  • The amount of Symlin you use will depend on whether you have type 1 or type 2 diabetes.

Important notes about Symlin use:

  • To reduce the risk of having a painful injection-site reaction, allow Symlin to come to room temperature before injecting
  • Use a new needle for each Symlin injection
  • Never mix Symlin and insulin and do not inject Symlin and insulin in the same site. Insulin can affect Symlin when they are mixed together.
  • Do not use Symlin if the liquid looks cloudy
  • Do not share your Symlin with another person, even if the needle is changed; you may give another person an infection or get an infection from them   
  • Do not use Symlin if you do not plan to eat; do not inject Symlin if you skip a meal. Wait until the next meal and take your usual dose of Symlin at that meal.
  • Check Symlin before you use it. Symlin should be clear and colorless. Do not use Symlin if the liquid looks cloudy or colored or has lumps or particles in it.
  • Your SymlinPen may look empty because Symlin is a clear and colorless liquid.
  • Small bubbles will not hurt you or affect your dose of Symlin.

Selecting your dose:

  1. Turn the dose dial to select the correct dose you need to inject
  2. Pull the dose knob straight out as far as it will go; you should hear a “clicking” sound while you are pulling the dose knob out
  3. Turn the dose knob forward or backward until you see the correct dose you need to inject
  4. Check the dose line to make sure you have loaded your full dose
  • you should see a line, arrow, and the number of your dose
  • if you do not see a line, arrow, and the number of your dose, do not inject the dose. Point the needle away from you, push the dose knob all the way in until it stops, then repeat step 1 to step 4 to get the accurate dose. 
  • once the Knob has been pulled out, the dial will not move and you cannot reset your dose; if the correct dose was not selected, push in the knob to discard the dose and repeat the instructions

Administering Symlin:

  1. Inject your Symlin exactly as your doctor has shown you
  2. Choose your injection site; Symlin is injected under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject Symlin at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN and insulin in the same site.
  3. Wipe the skin with an alcohol swab and let the injection site dry before you inject your dose
  4. Insert the needle into your skin
  5. Put your thumb on the dose knob and push the dose knob all the way in until it stops; hold the dose knob in and slowly count to 10
  6. Pull the needle out of your skin; if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab; do not rub the area
  7. If you see a drop or 2 of liquid on the needle tip is normal. It will not affect your dose. If you see more than 2 drops of liquid on the needle tip, you may not have received your full dose; do not inject another dose; talk to your doctor for help if this happens
  8. Carefully replace the outer needle cover
  9. Unscrew the capped needle with the outer needle cover on it and safely throw it away as instructed; do not store the Symlin pen with the needle attached or with the dose knob pulled out to prevent air bubbles
  10. Replace the pen cap

Other Requirements

Unopened Symlin:

  • Store Symlin in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it
  • Do not freeze Symlin. Do not use Symlin if it has been frozen.
  • Keep unopened Symlin out of the light

Opened Symlin:

  • Keep Symlin in the refrigerator or at room temperature up to 86°F (30°C) for 30 days; do not leave above 86°F (30°C)
  • Any Symlin in use should be thrown away after 30 days, even if it still has medicine in it

Unused Symlin (opened or unopened) should not be used after the expiration date printed on the carton and the label

Keep Symlin and all medicines out of the reach of children

Introduction

Antidiabetic agent; synthetic analog of human amylin.1 2

Interactions for Symlin

Orally Administered Drugs

Possible decreased rate of absorption of concomitantly administered oral drugs.1 Administer ≥1 hour prior to or 2 hours after pramlintide injection if rapid onset of a concomitantly orally administered drug is a critical determinant of effectiveness.1

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

Decreased peak plasma acetaminophen concentration and delayed time to peak plasma concentration 1

Administer acetaminophen 1–2 hours before or >2 hours after pramlintide injection1

Alcohol

Increased risk of hypoglycemia1

Alpha glucosidase inhibitors

Pramlintide-induced slowing of gastric emptying may influence drug effects1

Concomitant use not recommended1

Anticholinergic agents (e.g., atropine)

Pramlintide-induced slowing of gastric emptying may influence drug effects.1

Concomitant use not recommended1

ACE inhibitors

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Antidiabetic agents, oral

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Disopyramide

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Fibric acid derivatives

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Fluoxetine

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Insulin

Increased risk of severe hypoglycemia1

Pramlintide pharmacokinetics altered if pramlintide injection is mixed with insulin1 4 5 (See Compatibility under Stability.)

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Administer pramlintide and insulin as separate injections1 13

MAO inhibitors

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Pentoxifylline

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Propoxyphene

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Salicylates

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Sulfonamides

Increased risk of hypoglycemia1

Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1

Sympatholytic agents (e.g., β-adrenergic blocking agents, clonidine, guanethidine, reserpine)

May alter or decrease manifestations of hypoglycemia1

Advice to Patients

  • Importance of adhering to diet and exercise regimen.1 Importance of regular monitoring (preferably self-monitoring) of blood glucose and HbA1c.1

  • Importance of providing patient a copy of manufacturer’s patient information.1

  • Inform patients of the potential risks and advantages of pramlintide therapy.1

  • Importance of appropriate management of hypoglycemia and hyperglycemia, and assessment for other diabetes complications.1 Risk of hypoglycemia in patients receiving concomitant insulin therapy.1 Provide instructions regarding management of hypoglycemia, including recognition of symptoms, predisposing conditions, and treatment.1

  • Risk of nausea, particularly upon initiation of therapy.1

  • Importance of patient informing clinician of recurrent hypoglycemia or nausea.1

  • Provide instructions regarding proper use and storage of the injection.1 Importance of advising patient that if a dose is missed, resume the treatment regimen as prescribed with the next scheduled dose.1

  • Importance of providing instruction on proper injection technique and of administering pramlintide using a U-100 insulin syringe (preferably a 0.3-mL size for optimal accuracy) filled to the unit mark that corresponds to the volume to be injected.1

  • Importance of not mixing pramlintide with insulin.1 Importance of administering pramlintide and insulin as separate injections given at least 2 inches apart.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Uses For Symlin

Pramlintide injection is used to treat high blood sugar in patients with type 1 and type 2 diabetes who are also using mealtime insulin and have failed to control blood sugar levels.

This medicine is available only with your doctor's prescription.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trial Experience

Adverse Reactions (Excluding Hypoglycemia)

Adverse reactions (excluding hypoglycemia, which is discussed separately below) commonly associated with Symlin when coadministered with a fixed dose of insulin in the 26- to 52-week, placebo-controlled trials in patients with type 1 diabetes and patients with type 2 diabetes on mealtime insulin are presented in Table 1 and Table 2, respectively.

Table 1: Patients with Type 1 Diabetes: Common Adverse Reactions (Incidence ≥5% and Greater Incidence with Symlin Compared to Placebo) in 3 Pooled Placebo-Controlled Trials
Long-Term, Placebo-Controlled Studies
Symlin 30 or 60 mcg
3 Times Daily + Insulin
Placebo + Insulin
(N=716)
%
(N=538)
%
* Examples of inflicted injury included among others, abrasions, bruises, burns, fractures, lacerations, and muscle strains.

Nausea

48

17

Anorexia

17

2

Inflicted Injury*

14

10

Vomiting

11

7

Arthralgia

7

5

Fatigue

7

4

Allergic Reaction

6

5

Dizziness

5

4

Table 2: Patients with Type 2 Diabetes on Insulin: Common Adverse Reactions (Incidence ≥5% and Greater Incidence with Symlin Compared to Placebo) in 2 Pooled Placebo-Controlled Trials
Long-Term, Placebo-Controlled Studies
Symlin 120 mcg
2 Times Daily + Insulin
Placebo + Insulin
(N=292)
%
(N=284)
%

Nausea

28

12

Headache

13

7

Anorexia

9

2

Vomiting

8

4

Abdominal pain

8

7

Fatigue

7

4

Dizziness

6

4

Cough

6

4

Pharyngitis

5

2

Most adverse reactions were gastrointestinal in nature. The incidence of nausea is higher at the beginning of Symlin treatment and decreases with time in most patients. Gradual titration of the Symlin dose minimizes the incidence and severity of nausea [see Dosage and Administration (2)].

Severe Hypoglycemia

Coadministration of Symlin with mealtime insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes [see Boxed Warning and Warnings and Precautions (5.1)].

Two definitions of severe hypoglycemia were used in the Symlin clinical trials. Patient-ascertained severe hypoglycemia was defined as an episode of hypoglycemia requiring the assistance of another individual (including help administering oral carbohydrate) or requiring the administration of glucagon, intravenous glucose, or other medical intervention. Medically-assisted severe hypoglycemia was defined as an episode of hypoglycemia that was classified as a serious event by the investigator or that required glucagon, intravenous glucose, hospitalization, paramedic assistance or an emergency room visit. The incidence of severe hypoglycemia during the Symlin clinical development program is summarized in Table 3 and Table 4.

Table 3: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials and Dose Titration Trial in Patients with Type 1 Diabetes
Long-Term, Placebo-Controlled Studies
(No Insulin Dose-Reduction During Initiation)
Placebo-Controlled Dose Titration Study
Symlin + Insulin Placebo + Insulin Symlin + Insulin Placebo + Insulin
Severe Hypoglycemia 0 to 3 Months
(n=716)
>3 to 6 Months
(n=576)
0 to 3 Months
(n=538)
>3 to 6 Months
(n=470)
0 to 3 Months
(n=148)
>3 to 6 Months
(n=133)
0 to 3 Months
(n=147)
>3 to 6 Months
(n=138)
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. † Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Patient-Ascertained*

 Event Rate (events/patient-year)

1.55

0.82

1.33

1.06

0.69

0.49

0.28

0.3

  Subject Incidence (%)

16.8

11.1

10.8

8.7

13.5

10.5

6.1

5.8

Medically-Assisted†

  Event Rate (events/patient-year)

0.50

0.27

0.19

0.24

0.14

0.20

0.08

0.15

  Subject Incidence (%)

7.3

5.2

3.3

4.3

3.4

4.5

2.0

2.9

Table 4: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials in Patients with Type 2 Diabetes Using Insulin
Long-Term, Placebo-Controlled Studies
(No Insulin Dose-Reduction During Initiation)
Symlin + Insulin Placebo + Insulin
Severe Hypoglycemia 0 to 3 Months
(n=292)
>3 to 6 Months
(n=255)
0 to 3 Months
(n=284)
>3 to 6 Months
(n=251)
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. † Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Patient-Ascertained*

  Event Rate (events/patient-year)

0.45

0.39

0.24

0.13

  Subject Incidence (%)

8.2

4.7

2.1

2.4

Medically-Assisted†

  Event Rate (events/patient-year)

0.09

0.02

0.06

0.07

  Subject Incidence (%)

1.7

0.4

0.7

1.2

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Symlin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Injection site reactions • Pancreatitis

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

A two-year carcinogenicity study was conducted in CD-1 mice with doses of 0.2, 0.5, and 1.2 mg/kg/day of Symlin (32, 67, and 159 times the exposure resulting from the human dose of 360 mcg/day based on area under the plasma concentration curve or AUC, respectively). No drug-induced tumors were observed. A two-year carcinogenicity study was conducted in Sprague-Dawley rats with doses of 0.04, 0.2, and 0.5 mg/kg/day of Symlin (3, 9, and 25 times the exposure resulting from the human dose of 360 mcg/day based on AUC, respectively). No drug-induced tumors were observed in any organ.

Mutagenesis

Symlin was not mutagenic in the Ames test and did not increase chromosomal aberration in the human lymphocytes assay. Symlin was not clastogenic in the in vivo mouse micronucleus test or in the chromosomal aberration assay utilizing Chinese hamster ovary cells.

Impairment of Fertility

Administration of 0.3, 1, or 3 mg/kg/day of Symlin (8, 17, and 82 times the exposure resulting from the human dose of 360 mcg/day of mcg based on body surface area) had no significant effects on fertility in male or female rats. The highest dose of 3 mg/kg/day resulted in dystocia in 8/12 female rats secondary to significant decreases in serum calcium levels.

Clinical Studies

A total of 2333 patients with type 1 diabetes and 1852 patients with type 2 diabetes received Symlin in controlled clinical trials.

Type 1 Diabetes

The efficacy and safety of Symlin were evaluated in 3 (26-52-week), randomized, double-blind, placebo-controlled trials in patients with type 1 diabetes. In these studies, insulin adjustments were minimized in order to isolate the Symlin effect with insulin adjustments allowed, at the investigator's discretion, when excessive hypoglycemia was encountered. Patients participating in these 3 trials had a mean age of 40 years, a mean duration of diabetes of 17 years, and a mean body mass index of 25.9 kg/m2.

Table 6 summarizes the 6-month results for those patients assigned to the 30 or 60 mcg dose of Symlin or placebo.

Table 6: Mean (SE) Change in HbA1c and Insulin at 6 Months in the Double-Blind, Placebo-Controlled Studies in Patients with Type 1 Diabetes for the Intent-to-Treat Population
Trial 1 Trial 2 Trial 3
Variable Symlin
(30/60 mcg)
Placebo Symlin
(60 mcg)
Placebo Symlin
(60 mcg TID)
Symlin
(60 mcg QID)
Placebo
N=243 N=237 N=148 N=147 N=164 N=161 N=154
SD: standard deviation; LSM: least squares mean; SE: standard error; U: Units; NM: not measured; TID: 3 times a day; QID: 4 times a day.
* Statistically significant reduction compared to placebo (p-value <0.05).

Baseline HbA1c (%) (SD)

8.7
(1.33)

8.9
(1.46)

9.0
(1.12)

9.1
(1.08)

8.9
(1.1)

8.9
(1.0)

9.0
(1.1)

LSM Change in HbA1c at 6 Months Relative to Baseline (%) (SE)

–0.58
(0.07)*

–0.25
(0.07)

–0.24
(0.09)*

+0.08
(0.09)

–0.44
(0.07)*

–0.44
(–0.07)

–0.19
(0.08)

Placebo-
Subtracted LSM change in HbA1c at 6 Months (%)

–0.34*

NA

–0.32*

NA

–0.25*

–0.25*

NA

Mean Insulin Doses at Baseline: Mealtime/Bolus (U) (SE)

NM

NM

29.5
(1.4)

28.5
(1.1)

19.9
(1.2)

19.8
(2.2)

19.8
(1.3)

Mean Change in Insulin Doses (U) at 6 Months: Mealtime/Bolus (SE)

NM

NM

–2.0
(0.5)*

+0.3
(0.4)

+0.6
(0.8)

–0.8
(0.7)

+0.3
(1.4)

Mean Insulin Doses at Baseline: Basal (U) (SE)

NM

NM

21.0
(1.1)

21.0
(1.1)

33.1
(1.7)

33.7
(1.6)

31.9
(1.8)

Mean Change in Insulin Doses (U) at 6 Months: Basal (SE)

NM

NM

+0.2
(0.3)

–0.3
(0.4)

–0.1

(0.9)

–0.6
(0.7)

+0.6
(0.7)

In the three studies, from a mean baseline body weight of 75.3 kg, 73.3 kg, and 76.6 kg, respectively, after randomization there were corresponding mean reductions of –0.8 kg, –1.6 kg, and –1.3 kg (60 mcg TID) and –0.8 kg (60 mcg QID) in the Symlin treatment group compared to mean increases of +0.8 kg, +0.4 kg, and +0.7 kg in the placebo treatment group.

Symlin Dose-Titration Study

A dose-titration study of Symlin was conducted in patients with type 1 diabetes who had a mean age of 41 years, a mean duration of diabetes of 20 years, and a mean body mass index of 28 kg/m2. Patients with a mean baseline HbA1c of 8.1% (range 6.5%-10.7%) were randomized to receive either Symlin or placebo, both administered before major meals as add-on to insulin therapy. Symlin was initiated at a dose of 15 mcg and titrated upward at weekly intervals in 15 mcg increments to maintenance doses of 30 or 60 mcg, based on whether patients experienced nausea. Upon initiation of Symlin, the insulin dose (mostly the mealtime insulin) was reduced by 30% to 50% in order to minimize the occurrence of hypoglycemia. Once the maintenance dose of Symlin was reached, insulin dose adjustments were made according to standard clinical practice, based on pre- and post-meal blood glucose monitoring.

Table 7 summarizes the 6-month results for the dose-titration study.

Table 7: Mean (SE) Change in HbA1c and Insulin at 6 Months in the Dose-Titration Study in Patients with Type 1 Diabetes for Intent-to-Treat Population
Variable Symlin
(all doses)
Placebo
N=148 N=147
SD: standard deviation; LSM: least squares mean; SE: standard error; U: Units.
* Statistically significant reduction compared to placebo (p-value <0.05).

Mean Baseline HbA1c (%), (SD)

8.1 (0.8)

8.1 (0.8)

LSM Change in HbA1c at Week 29 Relative to Baseline (%)

–0.47 (0.07)

–0.49 (0.07)

Placebo-Subtracted LSM change in HbA1c at 6 Months (%) (SE)

0.03 (0.10)

NA

Mean Insulin Doses at Baseline: Mealtime/Bolus (U) (SD)

26.5 (14.2)

28.4 (16.3)

Mean Percent Change in Insulin Doses (U) at 6 Months: Mealtime/Bolus (SE)

–7.1 (0.9)*

–2.4 (1.2)

Mean Insulin Doses at Baseline: Basal (U) (SD)

29.4 (19.6)

28.1 (17.5)

Mean Change in Insulin Doses (U) at 6 Months: Basal (SE)

+1.4 (0.9)

+2.6 (1.2)

In the dose titration study, from mean baseline body weight of 81.5 kg, after randomization there was a mean reduction of –1.33 kg in the Symlin treatment group compared to a mean increase of +1.25 kg in the placebo treatment group.

Type 2 Diabetes

The efficacy and safety of Symlin were evaluated in 2 (a 26-week and a 52-week) randomized, double-blind, placebo-controlled trials in patients with type 2 diabetes. These trials enrolled patients with inadequate glycemic control (HbA1c >8%) on fixed dose insulin. In both trials, Symlin or placebo was added to existing insulin therapies. Concomitant use of a sulfonylurea and/or metformin was permitted. Insulin doses were to be kept as stable as possible throughout the treatment period to isolate the Symlin effect.

Patients participating in these 2 trials had a mean age of 57 years and a mean duration of diabetes of 13 years. Mean body mass index was 32.9 kg/m2 for Symlin and 32.2 kg/m2 for placebo.

Table 8 summarizes the 6-month results for each trial for those patients assigned to the 120 mcg dose of Symlin and placebo.

Table 8: Mean (SE) Change in HbA1c and Insulin at 6 Months in the Double-Blind, Placebo-Controlled Studies in Patients with Type 2 Diabetes for the Intent-to-Treat Population
Trial 1 Trial 2
Variable Symlin
(120 mcg)
Placebo Symlin
(120 mcg)
Placebo
N=166 N=161 N=126 N=123
SD: standard deviation; LSM: least squares mean; SE: standard error; U: Units.
* Statistically significant reduction compared to placebo (p-value <0.05).

Baseline HbA1c (%) (SD)

9.0 (0.08)

9.3 (0.10)

9.3 (1.1)

9.5 (1.4)

LSM Change in HbA1c at 6 Months Relative to Baseline (%) (SE)

–0.66 (0.08)*

–0.32 (0.09)

–0.36 (0.10)*

–0.06 (0.10)

Placebo-Subtracted LSM change in HbA1c at 6 Months (%)

–0.34*

NA

–0.30*

NA

Insulin Dose at Baseline: Mealtime/Bolus (U) (SE)

20.7 (1.6)

21.4 (1.5)

22.2 (1.8)

22.0 (1.6)

Mean Change in Insulin Doses (U) at 6 Months: Mealtime/Bolus (SE)

–0.7 (0.5)

–0.3 (0.6)

–0.0 (0.8)*

+1.6 (0.7)

Insulin Dose at Baseline: Basal (U) (SE)

48.0 (1.9)

52.4 (2.1)

33.2 (1.4)

30.9 (1.6)

Mean Change in Insulin Doses (U) at 6 Months: Basal (SE)

+0.01 (0.8)

+1.1 (1.0)

–1.2 (0.8)

+1.3 (0.7)

In both studies, from a mean baseline body weight of 96.7 kg, and 85.6 kg, respectively, after randomization there were corresponding mean reductions of –1.4 kg, and –1.6 kg in the Symlin treatment group compared to mean increases of +0.3 kg, and +0.1 kg in the placebo treatment group.

(web3)