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CompletedNCT00467649Updated Apr 14, 2015Results posted

A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

A Phase 4 interventional study of pramlintide acetate (Symlin) and rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 37 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-14.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Symlin
  • Amylin
  • insulin
  • Humalog
  • Novolog
  • Apidra
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 112 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has a clinical diagnosis of type 2 diabetes mellitus
  • Has an HbA1c >7.0% and ≤10.0%
  • Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2
  • Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy

Exclusion criteria

Exclusion Criteria:

  • Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
  • Requires the use of drugs that stimulate gastrointestinal motility
  • Has been previously treated with Symlin (or has participated in a Symlin clinical study)
  • Is currently being treated with any of the following medications: *Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat [Xenical®] and sibutramine [Meridia®]); *Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; *Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide [Reglan®]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; *Investigational medications
  • Has a history or presence of any of the following: *Eating disorders (including anorexia and/or bulimia); *Bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
  • Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
  • Has donated blood within 30 days of study start or plans to donate blood during the duration of the study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    Group A

    Drug: pramlintide acetate (Symlin) · Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

  • Active comparator
    Group B

    Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) · Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

Interventions

  • Drugpramlintide acetate (Symlin)

    subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals

    Also known as: Symlin

  • Drugrapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])

    subcutaneous injection, dosing based on titration guidelines

  • Drugbasal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

    subcutaneous injection, dosing based on titration guidelines

06

What researchers measure

Primary outcomes

  1. The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia

    A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.

    Time frame: 24 Weeks

Secondary outcomes

  1. Percentage of Patients Achieving HbA1c <=7% at Week 24

    This is a component of the primary endpoint

    Time frame: 24 Weeks

  2. Percentage of Patients With no Weight Gain at Week 24

    This is a component of the primary endpoint

    Time frame: 24 Weeks

  3. Percentage of Patients With a Severe Hypoglycemia Adverse Event

    This is a component of the primary endpoint.

    Time frame: 24 Weeks

  4. Change in HbA1c From Baseline at Week 24

    Baseline values are presented in the Baseline Characteristics section

    Time frame: From Baseline to Week 24

  5. Change in Body Weight From Baseline at Week 24

    Baseline values are presented in the Baseline Characteristics section

    Time frame: From Baseline to Week 24

  6. Change in Waist Circumference From Baseline at Week 24

    Baseline values are presented in the Baseline Characteristics section

    Time frame: From Baseline to Week 24

  7. Change in Fasting Plasma Glucose From Baseline at Week 24

    Baseline values are presented in the Baseline Characteristics section

    Time frame: From Baseline to Week 24

  8. Fasting Serum Lipids Change From Baseline to Week 24

    Time frame: Baseline, week 24

  9. Phase 2: Change in HbA1c at Week 36

    Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).

    Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

  10. Phase 2: Change in Body Weight at Week 36

    Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).

    Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

Other outcomes

  1. Hypoglycemia Adverse Events

    MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating. MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion). SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.

    Time frame: 36 weeks

07

Results

Posted Jun 4, 2009

Participant flow

Phase 1 (Randomized Population)
Participant flow — Phase 1 (Randomized Population)
MilestoneGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Group C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
Started57560000
Intent to treat56560000
Completed48500000
Not completed960000
Withdrew: Adverse event200000
Withdrew: Investigator decision100000
Withdrew: Lost to follow-up240000
Withdrew: Withdrawal of consent420000
Phase 2 (Intent-to-Treat Population)
Participant flow — Phase 2 (Intent-to-Treat Population)
MilestoneGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Group C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
Started0017311436
Completed0017291435
Not completed000201
Withdrew: Lost to follow-up000100
Withdrew: Protocol violation000100
Withdrew: Withdrawal of consent000001

Outcome measures

PrimaryThe Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia

A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.

Time frame:
24 Weeks
Reported as:
Number · Percent
The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
PercentGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia30.410.7
Statistical analysis
  • Group A (Phase 1 SYMLIN) vs Group B (Phase 1 RA Insulin) · Fisher Exact · p = 0.0180
SecondaryPercentage of Patients Achieving HbA1c <=7% at Week 24

This is a component of the primary endpoint

Time frame:
24 Weeks
Reported as:
Number · Percent
Percentage of Patients Achieving HbA1c <=7% at Week 24
PercentGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Percentage of Patients Achieving HbA1c <=7% at Week 2444.655.4
SecondaryPercentage of Patients With no Weight Gain at Week 24

This is a component of the primary endpoint

Time frame:
24 Weeks
Reported as:
Number · Percent
Percentage of Patients With no Weight Gain at Week 24
PercentGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Percentage of Patients With no Weight Gain at Week 2446.414.3
SecondaryPercentage of Patients With a Severe Hypoglycemia Adverse Event

This is a component of the primary endpoint.

Time frame:
24 Weeks
Reported as:
Number · Percent
Percentage of Patients With a Severe Hypoglycemia Adverse Event
PercentGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Percentage of Patients With a Severe Hypoglycemia Adverse Event0.00.0
SecondaryChange in HbA1c From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent
Change in HbA1c From Baseline at Week 24
PercentGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Change in HbA1c From Baseline at Week 24-1.11 ± 0.17-1.27 ± 0.17
SecondaryChange in Body Weight From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · kg
Change in Body Weight From Baseline at Week 24
kgGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Change in Body Weight From Baseline at Week 240.02 ± 0.684.65 ± 0.68
SecondaryChange in Waist Circumference From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · cm
Change in Waist Circumference From Baseline at Week 24
cmGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Change in Waist Circumference From Baseline at Week 24-0.63 ± 0.872.17 ± 0.86
SecondaryChange in Fasting Plasma Glucose From Baseline at Week 24

Baseline values are presented in the Baseline Characteristics section

Time frame:
From Baseline to Week 24
Reported as:
Mean · mg/dL
Change in Fasting Plasma Glucose From Baseline at Week 24
mg/dLGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Change in Fasting Plasma Glucose From Baseline at Week 24-29.0 ± 7.32-37.8 ± 7.69
SecondaryFasting Serum Lipids Change From Baseline to Week 24
Time frame:
Baseline, week 24
Reported as:
Mean · mg/dL
Fasting Serum Lipids Change From Baseline to Week 24
mg/dLGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)
Total Cholesterol-1.81 ± 5.8265.27 ± 4.649
HDL1.11 ± 1.1901.65 ± 1.075
LDL2.36 ± 4.4569.12 ± 3.865
Triglycerides-28.96 ± 12.442-31.98 ± 13.883
SecondaryPhase 2: Change in HbA1c at Week 36

Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).

Time frame:
Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Reported as:
Mean · Percent
Phase 2: Change in HbA1c at Week 36
PercentGroup C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
Phase 1 Baseline8.35 ± 0.2148.03 ± 0.1407.85 ± 0.1838.38 ± 0.145
Change From Phase 1 Baseline to Week 36-1.96 ± 0.238-0.68 ± 0.174-1.49 ± 0.189-0.99 ± 0.157
Phase 2 Baseline at Week 246.26 ± 0.1217.57 ± 0.1716.14 ± 0.1077.32 ± 0.170
Change From Phase 2 Baseline to Week 360.14 ± 0.062-0.23 ± 0.1230.22 ± 0.0970.07 ± 0.113
SecondaryPhase 2: Change in Body Weight at Week 36

Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).

Time frame:
Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Reported as:
Mean · kg
Phase 2: Change in Body Weight at Week 36
kgGroup C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
Phase 1 Baseline109.98 ± 4.916104.83 ± 3.959104.42 ± 7.341105.30 ± 2.210
Change From Phase 1 Baseline to Week 36-0.80 ± 2.0961.34 ± 0.9333.90 ± 1.4884.51 ± 0.761
Phase 2 Baseline at Week 24108.50 ± 5.656105.67 ± 4.045107.87 ± 7.801110.68 ± 2.507
Change From Phase 2 Baseline to Week 360.69 ± 0.6540.50 ± 0.3030.44 ± 0.518-0.86 ± 0.353
Other pre-specifiedHypoglycemia Adverse Events

MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating. MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion). SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.

Time frame:
36 weeks
Reported as:
Number · participants
Hypoglycemia Adverse Events
participantsGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Group C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
Mild3146718919
Moderate12130123
Severe000000

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A (Phase 1 SYMLIN)—1/56 (1.8%)29/56 (51.8%)
Group B (Phase 1 RA Insulin)—5/56 (8.9%)28/56 (50%)
Group C (Phase 2 SYMLIN)—0/17 (0%)9/17 (52.9%)
Group D (Phase 2 SYMLIN+RA)—0/31 (0%)11/31 (35.5%)
Group E (Phase 2 RA Insulin)—0/14 (0%)4/14 (28.6%)
Group F (Phase 2 RA Insulin + SYMLIN)—0/36 (0%)11/36 (30.6%)
Most frequent serious events
Most frequent serious events
EventGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Group C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
Coronary artery diseaseCardiac disorders1/561/560/170/310/140/36
Biliary dyskinesiaHepatobiliary disorders0/561/560/170/310/140/36
SyncopeNervous system disorders0/561/560/170/310/140/36
CellulitisInfections and infestations0/561/560/170/310/140/36
Cardiac failure congestiveCardiac disorders0/561/560/170/310/140/36
Non-cardiac chest painGeneral disorders0/561/560/170/310/140/36
Ischaemic cerebral infarctionNervous system disorders0/561/560/170/310/140/36
Most frequent other events
Showing 10 of 29
Most frequent other events
EventGroup A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Group C (Phase 2 SYMLIN)Group D (Phase 2 SYMLIN+RA)Group E (Phase 2 RA Insulin)Group F (Phase 2 RA Insulin + SYMLIN)
NauseaGastrointestinal disorders12/560/560/172/310/144/36
Upper respiratory tract infectionInfections and infestations7/565/561/172/311/141/36
BronchitisInfections and infestations0/560/560/173/310/140/36
DiarrhoeaGastrointestinal disorders5/560/560/170/310/142/36
NasopharyngitisInfections and infestations3/565/561/171/311/140/36
SinusitisInfections and infestations2/565/561/171/310/141/36
ArthralgiaMusculoskeletal and connective tissue disorders3/565/560/170/310/140/36
Back painMusculoskeletal and connective tissue disorders5/560/560/170/310/140/36
HeadacheNervous system disorders5/561/560/170/310/140/36
CoughRespiratory, thoracic and mediastinal disorders2/565/560/170/310/140/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
<=18 years000
Between 18 and 65 years464995
>=65 years10717
Age, Continuous
Age, Continuous(years)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
Mean55.0 ± 11.3553.6 ± 9.7054.3 ± 10.53
Sex: Female, Male
Sex: Female, Male(Participants)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
Female221941
Male343771
Region of Enrollment
Region of Enrollment(participants)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
United States5656112
Fasting Plasma Glucose
Fasting Plasma Glucose(mg/dL)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
Mean155.1 ± 39.60164.3 ± 49.61159.7 ± 44.92
Fasting Serum Lipids
Fasting Serum Lipids(mg/dL)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
Total Cholesterol167.53 ± 47.054169.86 ± 49.121168.70 ± 47.903
HDL44.71 ± 11.89341.77 ± 9.46843.23 ± 10.790
LDL89.15 ± 38.38690.41 ± 34.11489.78 ± 36.133
Triglycerides174.13 ± 108.257193.59 ± 159.508183.95 ± 136.273
HbA1c
HbA1c(Percent)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
Mean8.19 ± 0.8408.25 ± 0.8168.22 ± 0.825
Waist Circumference
Waist Circumference(cm)Group A (Phase 1 SYMLIN)Group B (Phase 1 RA Insulin)Total
Mean116.31 ± 15.427117.15 ± 13.198116.73 ± 14.297

1 further baseline measures are reported on the registry.

08

Study locations

37 sites
  • Research Site
    Northport, Alabama, United States
  • Research Site
    Phoenix, Arizona, United States
  • Research Site
    Loma Linda, California, United States
  • Research Site
    Aurora, Colorado, United States
  • Research Site
    Hollywood, Florida, United States
  • Research Site
    Maitland, Florida, United States
  • Research Site
    Miami, Florida, United States
  • Research Site
    North Miami Beach, Florida, United States
  • Research Site
    Plantation, Florida, United States
  • Research Site
    Roswell, Georgia, United States
  • Research Site
    Peoria, Illinois, United States
  • Research Site
    Indianapolis, Indiana, United States
  • Research Site
    Wichita, Kansas, United States
  • Research Site
    Lexington, Kentucky, United States
  • Research Site
    Baton Rouge, Louisiana, United States
  • Research Site
    Baltimore, Maryland, United States
  • Research Site
    Detroit, Michigan, United States
  • Research Site
    Grand Rapids, Michigan, United States
  • Research Site
    Jackson, Mississippi, United States
  • Research Site
    St. Louis, Missouri, United States
  • Research Site
    Butte, Montana, United States
  • Research Site
    Las Vegas, Nevada, United States
  • Research Site
    Hamilton, New Jersey, United States
  • Research Site
    Albuquerque, New Mexico, United States
  • Research Site
    Albany, New York, United States
  • Research Site
    Staten Island, New York, United States
  • Research Site
    Mentor, Ohio, United States
  • Research Site
    Portland, Oregon, United States
  • Research Site
    Bridgeville, Pennsylvania, United States
  • Research Site
    Philadelphia, Pennsylvania, United States
  • Research Site
    Aiken, South Carolina, United States
  • Research Site
    Bartlett, Tennessee, United States
  • Research Site
    Nashville, Tennessee, United States
  • Research Site
    Austin, Texas, United States
  • Research Site
    Dallas, Texas, United States
  • Research Site
    Olympia, Washington, United States
  • Research Site
    Spokane, Washington, United States
09

References and documents

Publications

  • Peyrot M, Rubin RR, Polonsky WH, Best JH. Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. Curr Med Res Opin. 2010 May;26(5):1047-54. doi: 10.1185/03007991003634759. PubMed 20199136 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00467649
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 1, 2007
Start date
May 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Jun 4, 2009
Last update
Apr 14, 2015

Study contacts

Lisa Porter, MD
study director · Amylin Pharmaceuticals, LLC.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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