Clinical trial NCT00467649: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Symlin
Amylin
insulin
Humalog
Novolog
Apidra
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-01
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
timeFrame: 24 Weeks
Secondary outcomes:
measure: Percentage of Patients Achieving HbA1c <=7% at Week 24
timeFrame: 24 Weeks
measure: Percentage of Patients With no Weight Gain at Week 24
timeFrame: 24 Weeks
measure: Percentage of Patients With a Severe Hypoglycemia Adverse Event
timeFrame: 24 Weeks
measure: Change in HbA1c From Baseline at Week 24
timeFrame: From Baseline to Week 24
measure: Change in Body Weight From Baseline at Week 24
timeFrame: From Baseline to Week 24
measure: Change in Waist Circumference From Baseline at Week 24
timeFrame: From Baseline to Week 24
measure: Change in Fasting Plasma Glucose From Baseline at Week 24
timeFrame: From Baseline to Week 24
measure: Fasting Serum Lipids Change From Baseline to Week 24
timeFrame: Baseline, week 24
measure: Phase 2: Change in HbA1c at Week 36
timeFrame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
measure: Phase 2: Change in Body Weight at Week 36
timeFrame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Other outcomes:
measure: Hypoglycemia Adverse Events
timeFrame: 36 weeks
Locations:
city: Northport
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Loma Linda
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: North Miami Beach
country: United States
facility: Research Site
state: Florida
city: Plantation
country: United States
facility: Research Site
state: Florida
city: Roswell
country: United States
facility: Research Site
state: Georgia
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Butte
country: United States
facility: Research Site
state: Montana
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Hamilton
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Albany
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Mentor
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Bridgeville
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Aiken
country: United States
facility: Research Site
state: South Carolina
city: Bartlett
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Olympia
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References:
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.