basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00467649
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACA401
Secondary IDs
Not provided
Brief Title
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
Official Title
A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2007
Primary Completion Date
Apr 2008Actual
Completion Date
Apr 2008Actual
First Submitted Date
Apr 27, 2007
First Submission Date that Met QC Criteria
Apr 30, 2007
First Posted Date
May 1, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 10, 2009
Results First Submitted that Met QC Criteria
Apr 10, 2009
Results First Posted Date
Jun 4, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 26, 2015
Last Update Posted Date
Apr 14, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Symlin
Amylin
insulin
Humalog
Novolog
Apidra
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A
Experimental
Drug: pramlintide acetate (Symlin)
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pramlintide acetate (Symlin)
Drug
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
Group A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
24 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Patients Achieving HbA1c <=7% at Week 24
This is a component of the primary endpoint
24 Weeks
Percentage of Patients With no Weight Gain at Week 24
This is a component of the primary endpoint
Other Outcomes
Measure
Description
Time Frame
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.
Eligibility Module
Eligibility Criteria
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:
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
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
subcutaneous injection, dosing based on titration guidelines
Group B
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Drug
subcutaneous injection, dosing based on titration guidelines
Group A
Group B
24 Weeks
Percentage of Patients With a Severe Hypoglycemia Adverse Event
This is a component of the primary endpoint.
24 Weeks
Change in HbA1c From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
From Baseline to Week 24
Change in Body Weight From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
From Baseline to Week 24
Change in Waist Circumference From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
From Baseline to Week 24
Change in Fasting Plasma Glucose From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
From Baseline to Week 24
Fasting Serum Lipids Change From Baseline to Week 24
Baseline, week 24
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).
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).
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
FG002
Group C (Phase 2 SYMLIN)
Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
FG003
Group D (Phase 2 SYMLIN+RA)
Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
FG004
Group E (Phase 2 RA Insulin)
Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
FG005
Group F (Phase 2 RA Insulin + SYMLIN)
Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
FG00057 subjectsOne patient randomized to the SYMLIN group withdrew consent prior to receiving the first dose
FG00156 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Intent to Treat
FG00056 subjects
FG00156 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00048 subjects
FG00150 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0009 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Investigator Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal of Consent
FG0004 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2 (Intent-to-Treat Population)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00217 subjects
FG00331 subjects
FG00414 subjects
FG00536 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00217 subjects
FG00329 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
BG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00056
BG00156
BG002112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.0± 11.35
BG00153.6± 9.70
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00119
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00056
BG00156
BG002
Fasting Plasma Glucose
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG000155.1± 39.60
BG001164.3± 49.61
BG002
Fasting Serum Lipids
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Total Cholesterol
Title
Measurements
BG000167.53± 47.054
BG001169.86± 49.121
BG002
HbA1c
Mean
Standard Deviation
Percent
Title
Denominators
Categories
Title
Measurements
BG0008.19± 0.840
BG0018.25± 0.816
BG002
Waist Circumference
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000116.31± 15.427
BG001117.15± 13.198
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG000107.87± 21.893
BG001103.46± 17.908
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
Posted
Number
Percent
24 Weeks
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG00056
OG00156
Title
Denominators
Categories
Title
Measurements
OG00030.4
OG00110.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.0180
95
No
Superiority or Other
Secondary
Percentage of Patients Achieving HbA1c <=7% at Week 24
This is a component of the primary endpoint
Phase 1 Intent-to-Treat
Posted
Number
Percent
24 Weeks
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Percentage of Patients With no Weight Gain at Week 24
This is a component of the primary endpoint
Phase 1 Intent-to-Treat
Posted
Number
Percent
24 Weeks
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Percentage of Patients With a Severe Hypoglycemia Adverse Event
This is a component of the primary endpoint.
Phase 1 Intent-to-Treat
Posted
Number
Percent
24 Weeks
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Change in HbA1c From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
Posted
Least Squares Mean
Standard Error
Percent
From Baseline to Week 24
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Change in Body Weight From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
Posted
Least Squares Mean
Standard Error
kg
From Baseline to Week 24
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Change in Waist Circumference From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.
Posted
Least Squares Mean
Standard Error
cm
From Baseline to Week 24
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Change in Fasting Plasma Glucose From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Phase 1 Intent-to-Treat
Posted
Mean
Standard Error
mg/dL
From Baseline to Week 24
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
Fasting Serum Lipids Change From Baseline to Week 24
Phase 1 Intent-to-Treat
Posted
Mean
Standard Error
mg/dL
Baseline, week 24
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Units
Counts
Participants
OG000
Secondary
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).
Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
OG001
Group D (Phase 2 SYMLIN+RA)
Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
OG002
Group E (Phase 2 RA Insulin)
Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
OG003
Group F (Phase 2 RA Insulin + SYMLIN)
Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
Secondary
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).
Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
OG001
Group D (Phase 2 SYMLIN+RA)
Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
OG002
Group E (Phase 2 RA Insulin)
Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
OG003
Group F (Phase 2 RA Insulin + SYMLIN)
Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
Other Pre-specified
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.
Posted
Number
participants
36 weeks
ID
Title
Description
OG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
OG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
OG002
Group C (Phase 2 SYMLIN)
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group A (Phase 1 SYMLIN)
SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1
56
29
56
EG001
Group B (Phase 1 RA Insulin)
Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
5
56
28
56
EG002
Group C (Phase 2 SYMLIN)
Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
0
17
9
17
EG003
Group D (Phase 2 SYMLIN+RA)
Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
0
31
11
31
EG004
Group E (Phase 2 RA Insulin)
Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
0
14
4
14
EG005
Group F (Phase 2 RA Insulin + SYMLIN)
Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
0
36
11
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery disease
Cardiac disorders
EG0001 events1 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG0030 events0 affected31 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected36 at risk
Biliary dyskinesia
Hepatobiliary disorders
EG0000 events0 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Syncope
Nervous system disorders
EG0000 events0 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Cellulitis
Infections and infestations
EG0000 events0 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Cardiac failure congestive
Cardiac disorders
EG0000 events0 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Non-cardiac chest pain
General disorders
EG0000 events0 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
EG0000 events0 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
EG00016 events12 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG0032 events2 affected31 at risk
EG0040 events0 affected14 at risk
EG0054 events4 affected36 at risk
Diarrhoea
Gastrointestinal disorders
EG0007 events5 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Chest pain
General disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0022 events1 affected17 at risk
EG003
Anaemia
Blood and lymphatic system disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Oedema peripheral
General disorders
EG0000 events0 affected56 at risk
EG0015 events4 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
EG0003 events3 affected56 at risk
EG0015 events5 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Bronchitis
Infections and infestations
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Gastroenteritis viral
Infections and infestations
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Influenza
Infections and infestations
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Otitis externa
Infections and infestations
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Sinusitis
Infections and infestations
EG0002 events2 affected56 at risk
EG0015 events5 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
EG0008 events7 affected56 at risk
EG0015 events5 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
EG0003 events3 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
EG0003 events3 affected56 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
EG0004 events3 affected56 at risk
EG0017 events5 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
EG0005 events5 affected56 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
EG0000 events0 affected56 at risk
EG0013 events3 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
EG0000 events0 affected56 at risk
EG0013 events3 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Headache
Nervous system disorders
EG00011 events5 affected56 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
EG0002 events2 affected56 at risk
EG0015 events5 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
EG0000 events0 affected56 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected17 at risk
EG003
Hypertension
Vascular disorders
EG0000 events0 affected56 at risk
EG0015 events5 affected56 at risk
EG0020 events0 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Peter Ohman, Medical Science Director
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
ID
Term
D003924
Diabetes Mellitus, Type 2
D007333
Insulin Resistance
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
D006946
Hyperinsulinism
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C105254
pramlintide
D061266
Insulin, Short-Acting
D061268
Insulin Lispro
D061267
Insulin Aspart
C479079
insulin glulisine
D000069036
Insulin Glargine
D000069057
Insulin Detemir
Ancestor Terms
ID
Term
D061385
Insulins
D010187
Pancreatic Hormones
D036361
Peptide Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D049528
Insulin, Long-Acting
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
14 subjects
FG00535 subjects
0 subjects
FG0051 subjects
1 subjects
FG0040 subjects
FG0050 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Withdrawal of Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
BG00046
BG00149
BG00295
>=65 years
BG00010
BG0017
BG00217
54.3
± 10.53
41
Male
BG00034
BG00137
BG00271
112
159.7
± 44.92
168.70
± 47.903
HDL
Title
Measurements
BG00044.71± 11.893
BG00141.77± 9.468
BG00243.23± 10.790
LDL
Title
Measurements
BG00089.15± 38.386
BG00190.41± 34.114
BG00289.78± 36.133
Triglycerides
Title
Measurements
BG000174.13± 108.257
BG001193.59± 159.508
BG002183.95± 136.273
8.22
± 0.825
116.73
± 14.297
105.67
± 20.032
56
OG00156
Title
Denominators
Categories
Title
Measurements
OG00044.6
OG00155.4
56
OG00156
Title
Denominators
Categories
Title
Measurements
OG00046.4
OG00114.3
56
OG00156
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
56
OG00156
Title
Denominators
Categories
Title
Measurements
OG000-1.11± 0.17
OG001-1.27± 0.17
56
OG00156
Title
Denominators
Categories
Title
Measurements
OG0000.02± 0.68
OG0014.65± 0.68
53
OG00156
Title
Denominators
Categories
Title
Measurements
OG000-0.63± 0.87
OG0012.17± 0.86
45
OG00150
Title
Denominators
Categories
Title
Measurements
OG000-29.0± 7.32
OG001-37.8± 7.69
47
OG00149
Title
Denominators
Categories
Total Cholesterol
Title
Measurements
OG000-1.81± 5.826
OG0015.27± 4.649
HDL
Title
Measurements
OG0001.11± 1.190
OG0011.65± 1.075
LDL
Title
Measurements
OG0002.36± 4.456
OG0019.12± 3.865
Triglycerides
Title
Measurements
OG000-28.96± 12.442
OG001-31.98± 13.883
Units
Counts
Participants
OG00017
OG00130
OG00214
OG00336
Title
Denominators
Categories
Phase 1 Baseline
Title
Measurements
OG0008.35± 0.214
OG0018.03± 0.140
OG0027.85± 0.183
OG0038.38± 0.145
Change From Phase 1 Baseline to Week 36
Title
Measurements
OG000-1.96± 0.238
OG001-0.68± 0.174
OG002-1.49± 0.189
OG003
Phase 2 Baseline at Week 24
Title
Measurements
OG0006.26± 0.121
OG0017.57± 0.171
OG0026.14± 0.107
OG003
Change From Phase 2 Baseline to Week 36
Title
Measurements
OG0000.14± 0.062
OG001-0.23± 0.123
OG0020.22± 0.097
OG003
Units
Counts
Participants
OG00017
OG00130
OG00214
OG00336
Title
Denominators
Categories
Phase 1 Baseline
Title
Measurements
OG000109.98± 4.916
OG001104.83± 3.959
OG002104.42± 7.341
OG003105.30± 2.210
Change From Phase 1 Baseline to Week 36
Title
Measurements
OG000-0.80± 2.096
OG0011.34± 0.933
OG0023.90± 1.488
OG003
Phase 2 Baseline at Week 24
Title
Measurements
OG000108.50± 5.656
OG001105.67± 4.045
OG002107.87± 7.801
OG003
Change From Phase 2 Baseline to Week 36
Title
Measurements
OG0000.69± 0.654
OG0010.50± 0.303
OG0020.44± 0.518
OG003
Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
OG003
Group D (Phase 2 SYMLIN+RA)
Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
OG004
Group E (Phase 2 RA Insulin)
Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
OG005
Group F (Phase 2 RA Insulin + SYMLIN)
Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2