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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pramlintide acetate (Symlin)
rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Symlin, Amylin, insulin, Humalog, Novolog, Apidra

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Patients Achieving HbA1c <=7% at Week 24
This is a component of the primary endpoint
Percentage of Patients With no Weight Gain at Week 24
This is a component of the primary endpoint
Percentage of Patients With a Severe Hypoglycemia Adverse Event
This is a component of the primary endpoint.
Change in HbA1c From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Change in Body Weight From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Change in Waist Circumference From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Change in Fasting Plasma Glucose From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Fasting Serum Lipids Change From Baseline to 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).
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).

Full Information

First Posted
April 27, 2007
Last Updated
March 26, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00467649
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Symlin, Amylin, insulin, Humalog, Novolog, Apidra

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pramlintide acetate (Symlin)
Other Intervention Name(s)
Symlin
Intervention Description
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
Intervention Type
Drug
Intervention Name(s)
rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
Intervention Description
subcutaneous injection, dosing based on titration guidelines
Intervention Type
Drug
Intervention Name(s)
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Intervention Description
subcutaneous injection, dosing based on titration guidelines
Primary Outcome Measure Information:
Title
The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
Description
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 Outcome Measure Information:
Title
Percentage of Patients Achieving HbA1c <=7% at Week 24
Description
This is a component of the primary endpoint
Time Frame
24 Weeks
Title
Percentage of Patients With no Weight Gain at Week 24
Description
This is a component of the primary endpoint
Time Frame
24 Weeks
Title
Percentage of Patients With a Severe Hypoglycemia Adverse Event
Description
This is a component of the primary endpoint.
Time Frame
24 Weeks
Title
Change in HbA1c From Baseline at Week 24
Description
Baseline values are presented in the Baseline Characteristics section
Time Frame
From Baseline to Week 24
Title
Change in Body Weight From Baseline at Week 24
Description
Baseline values are presented in the Baseline Characteristics section
Time Frame
From Baseline to Week 24
Title
Change in Waist Circumference From Baseline at Week 24
Description
Baseline values are presented in the Baseline Characteristics section
Time Frame
From Baseline to Week 24
Title
Change in Fasting Plasma Glucose From Baseline at Week 24
Description
Baseline values are presented in the Baseline Characteristics section
Time Frame
From Baseline to Week 24
Title
Fasting Serum Lipids Change From Baseline to Week 24
Time Frame
Baseline, week 24
Title
Phase 2: Change in HbA1c at Week 36
Description
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
Title
Phase 2: Change in Body Weight at Week 36
Description
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 Pre-specified Outcome Measures:
Title
Hypoglycemia Adverse Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Northport
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Loma Linda
State/Province
California
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
North Miami Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Plantation
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Hamilton
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Research Site
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Research Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Bridgeville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Aiken
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Bartlett
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20199136
Citation
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.
Results Reference
derived

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

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